Apparatus and methods for treating obstructions within body lumens

ABSTRACT

Apparatus and methods are provided for delivering fluid into a body lumen during a medical procedure. A distal end of an apparatus may be introduced into a body lumen, and a valve on the distal end may be opened to deliver fluid through a first lumen into the body lumen, e.g., contrast and/or other diagnostic or therapeutic agents. The valve may be closed, and a procedure may be performed within the body lumen, e.g., using a treatment element carried on the distal end. For example, the treatment element may include a balloon that may be inflated when fluid is delivered through the first lumen with the valve closed. Optionally, a prosthesis, energy source, drug platform, and the like may be carried by the balloon for treating the body lumen. In various embodiments, the valve may be located proximal or distal to the treatment element.

RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.14/803,112, filed Jul. 20, 2015, which is a divisional of U.S.application Ser. No. 13/216,208, filed Aug. 23, 2011 (now U.S. Pat. No.9,101,382, issued Aug. 11, 2015), which claims the benefit of U.S.Provisional Application Nos. 61/402,166, filed Aug. 25, 2010,61/463,537, filed Feb. 19, 2011, and 61/520,927, filed Jun. 17, 2011,and is a continuation-in-part of U.S. application Ser. No. 12/843,004,filed Jul. 23, 2010 (now U.S. Pat. No. 8,945,160, issued Feb. 3, 2015),which claims the benefit of U.S. Provisional Application Nos.61/271,627, filed Jul. 23, 2009, 61/283,035, filed Nov. 25, 2009,61/342,755, filed Apr. 19, 2010, and 61/397,854, filed Jun. 17, 2010,and is a continuation-in-part of U.S. application Ser. No. 12/497,135,filed Jul. 2, 2009 (now U.S. Pat. No. 8,043,313, issued Oct. 25, 2011),which claims the benefit of U.S. Provisional Application Nos.61/078,330, filed Jul. 3, 2008, 61/153,620, filed Feb. 18, 2009,61/214,667, filed Apr. 27, 2009, and 61/215,732, filed May 8, 2009, theentire disclosures of which are incorporated by reference herein.

FIELD OF THE INVENTION

The present invention relates generally to apparatus for performingprocedures within a body lumen of a patient, e.g., for removing ortreating obstructive material within a tubular graft, aorto-venousfistula, blood vessel, and the like. More particularly, the presentinvention relates to apparatus, e.g., catheters, for infusing fluidsinto a body lumen during a medical procedure, for example, proceduresinvolving removing or otherwise capturing thrombus or other obstructivematerial within a body lumen, dilating a body lumen, and/or delivering aprosthesis, and to methods for making and using such apparatus.

BACKGROUND

Flow within a blood vessel or other body lumen within a patient'svasculature may become constricted or ultimately interrupted for avariety of reasons. For example, a vessel may gradually narrow due toinflammation and/or cell proliferation. In addition, thrombus may formdue to such narrowing or other flow problems within a vessel.

For example, an aorto-venous graft may be implanted in an arm of apatient experiencing kidney failure, e.g., to facilitate dialysistreatment. Such grafts may be a fistula formed directly in the patient'sbody, e.g., through tissue between an adjacent artery and vein or othervessels, may be a xenograft implanted between two vessels, or may be asynthetic graft. Such grafts only have a limited life cycle due toinflammation, thrombus formation, and the like. Once such a graftbecomes sufficiently occluded or otherwise deteriorates, a new graftmust be implanted at a new location for subsequent treatment.

Accordingly, apparatus and methods for removing material fromaorto-venous grafts, blood vessels, or other body lumens and/orotherwise treating body lumens would be useful.

SUMMARY

The present invention is directed to apparatus for performing aprocedure within a body lumen of a patient, e.g., a tubular graft,aorto-venous fistula, blood vessel, and the like. More particularly, thepresent invention is directed to apparatus and methods for infusingfluids into a body lumen during a medical procedure, and/or for removingor otherwise capturing thrombus or other obstructive material within abody lumen, e.g., procedures involving removing obstructive or othermaterial, dilating a body lumen, delivering a prosthesis within a bodylumen, and/or other procedures.

In accordance with a first embodiment, an apparatus is provided forperforming a procedure within a body lumen that is operable in differentmodes to perform various functions, e.g., possibly reducing the numberof device exchanges during a procedure. For example, the apparatus mayinclude a shaft including a proximal end, a distal end sized forintroduction into a body lumen, a lumen extending therebetween, and aballoon on the distal end having an interior communicating with thelumen. The apparatus may also include a valve on the distal end of theshaft that selectively opens or closes an outlet communicating with thelumen. With the valve open, fluid introduced into the lumen may exit theoutlet into a body lumen adjacent the distal end. With the valve closed,fluid introduced into the lumen may expand the balloon from a contractedcondition to an expanded condition, e.g., to dilate an obstructionwithin a body lumen, to remove thrombus or other material within thebody lumen, to deliver a prosthesis carried on the distal end, todeliver drugs or other agents carried on the distal end, and the like.

In accordance with another embodiment, an apparatus is provided fortreating a body lumen that includes an elongate tubular outer memberincluding a proximal end, a distal end, and a first lumen extendingbetween the proximal and distal ends; an expandable balloon including aproximal end secured to the tubular member distal end, and a distal endincluding an outlet, the balloon including an interior communicatingwith the first lumen and the balloon outlet. An elongate inner member isslidably disposed within the first lumen that includes a proximal endadjacent the tubular member proximal end, and a distal end extendinginto, through, and/or beyond the balloon. The balloon and inner membermay include cooperating features providing a valve for selectivelyopening and closing the balloon outlet. For example, the valve mayinclude a sealing member on the distal end of the inner member sized tobe engaged with the balloon distal end to substantially seal the outletfrom fluid flow.

The inner member may be movable between a first position wherein thesealing member is spaced apart from the balloon distal end such thatfluid introduced through the first lumen passes through the ballooninterior and out the balloon outlet, and a second position wherein thesealing member substantially seals the balloon outlet such that fluidintroduced through the first lumen enters the balloon interior to expandthe balloon.

Optionally, the inner member may be biased towards one of the first andsecond positions, but may be selectively directed to the other of thefirst and second positions. For example, a tensioning element may beprovided within the balloon interior, e.g., coupled between the balloonand the inner member. In one embodiment, where the sealing member isdisposed within the balloon interior, the tensioning element may biasthe balloon distal end distally away from the sealing member, e.g., toprevent the balloon distal end from moving proximally when the sealingmember is actuated to open the valve. For example, the tensioningelement may be a compression spring that is compressed when the innermember is directed distally to close the valve, and may be allowed topartially relax when the inner member is directed proximally to open thevalve.

In another embodiment, where the sealing member is disposed distallybeyond the balloon outlet, the tensioning element may bias the balloondistal end distally, e.g., to engage the sealing member with the balloondistal end to substantially seal the outlet. For example, the tensioningelement may be coupled between a spring stop on the balloon and a collaror other attachment member on the inner member. When the inner member isadvanced distally to open the outlet, the tensioning element may becompressed between the spring stop and the collar. When the inner memberis released or directed to close the outlet, the tensioning element mayensure that the balloon distal end does not migrate proximally and/ormay automatically direct the inner member proximally to reseal orenhance resealing the outlet with the sealing member.

If desired, the distal end of the balloon may include a distal tipshaped and/or configured to facilitate sealing and/or opening theoutlet. For example, in one embodiment, the sealing member may include atapered proximal end, and the distal tip may be flared outwardly awayfrom the balloon such that the tapered proximal end of the sealingmember may be seated at least partially in the flared distal tip. Suchan embodiment may increase surface contact between the sealing memberand the distal end, which may enhance sealing the outlet. In addition oralternatively, the flared distal tip may maximize the free area of theoutlet when the sealing member is directed away from the outlet.

In another embodiment, a distal tip may be provided that is resilientlyexpandable, e.g., to increase surface contact between the sealing memberand the distal end of the balloon to enhance sealing the outlet. Forexample, the distal tip may be relatively thin compared to the distalend of the balloon such that, when the sealing member is directedproximally into the distal tip, the distal tip may expand and conform tothe shape of the sealing member. When the sealing member is directeddistally to open the outlet, the distal tip may resiliently return toits original size and/or shape.

Optionally, any of the apparatus herein may include a helical memberextending helically around the inner member within the balloon interiorand including a first end coupled to the tubular member distal end and asecond end coupled to the inner member distal end. In this embodiment,the inner member may be movable to a third position in which the innermember distal end is directed towards the tubular member distal end tocause the helical member to compress axially and expand radiallyoutwardly, thereby expanding the balloon to an expanded helical shape.

Optionally, in any of these embodiments, a coating may be provided on aninner surface of at least a portion of the balloon distal end, distaltip, and/or the sealing member, e.g., to reduce friction between theballoon distal end and/or distal tip and the sealing member in thesecond position.

In another option, in any of these embodiments, the distal end of theballoon may be sized to provide a predetermined resistance to fluid flowtherethrough. For example, a spring stop or other feature within thedistal end may partially obstruct the passage through the distal endleading to the outlet. Thus, if desired, with the outlet open, thedistal end may provide sufficient resistance to fluid flow therethroughthat fluid delivered into the balloon interior may at least partiallyexpand the balloon as well as deliver fluid through the outlet into abody lumen.

In yet another option, in any of these embodiments, the inner member mayinclude a “J” or other curved tip that extends beyond the balloon, e.g.,to facilitate guiding the tip, and consequently, the distal end of theapparatus into a branch from a body lumen. In this variation, the innermember may be partially decoupled from the tubular member such that theinner member may be rotated to change the orientation of the curved tip.For example, the inner member may be rotatable less than three hundredsixty degrees to limit rotation, e.g., to prevent excess torque frombeing applied to the inner member.

In still another option, the inner member may include a distal tip thatextends beyond the balloon, and that includes a guidewire lumen therein.For example, the distal tip may include a distal opening and a proximalsidewall opening and the guidewire lumen may extend therebetween, e.g.,to provide a “rapid-exchange” guidewire lumen on the distal tip.Alternatively, the inner member may include a guidewire lumen thatextends between the proximal and distal ends of the inner member.

In accordance with still another embodiment, an apparatus is providedfor treating a body lumen that includes an outer member including aproximal end, a distal end sized for introduction into a body lumen, anda first lumen extending between the proximal end and an outlet in thedistal end. An inner member is slidably disposed within the first lumenthat includes a proximal end adjacent the outer member proximal end, adistal portion extending distally beyond the outer member distal end,and a sealing member on or adjacent the distal portion. The inner membermay be movable between a first position wherein the sealing member isspaced from the outlet of the outer member such that fluid introducedthrough the first lumen passes through the outlet into a region aroundthe apparatus, and a second position wherein the sealing membersubstantially seals the outlet.

In one embodiment, an expandable balloon is provided on the distalportion and the sealing member includes one or more passagestherethrough such that, when the inner member is in the second positionto seal the outlet, fluid introduced through the first lumen passesthrough the one or more passages and enters the balloon interior toexpand the balloon. Alternatively, the distal portion may include one ormore passages communicating between the sealing member and a distal endof the inner member such that, when the inner member is in the secondposition to seal the outlet, fluid introduced through the first lumenpasses through the one or more passages and into the body lumen distallybeyond the distal portion. In addition or alternatively, other treatmentelements may be provided on the distal portion instead of or in additionto the balloon, such as a stent, stent-graft, prosthetic valve, and thelike.

In accordance with yet another embodiment, a method is provided forperforming a procedure that includes introducing a distal end of anapparatus into a body lumen of a patient, the apparatus including anouter tubular member including a first lumen extending between aproximal end and an outlet at a distal end thereof, an elongate innermember slidable within the first lumen and including a distal portionextending beyond the tubular member outlet, and a valve member disposedon or adjacent the inner member. The distal ends of the outer and innermembers may be introduced into a body lumen, e.g., via the patient'svasculature or other passages. An actuator on a proximal end of theapparatus may be activated to move the inner member to a first positionwherein the valve member is located away from the tubular member outlet,and fluid may be delivered through the first lumen such that the fluidexits the outlet proximal to the distal portion into the body lumen.

Thereafter, the inner member may be directed towards a second positionwherein the valve member substantially seals the outlet. A treatmentelement on the distal portion may then be manipulated to perform amedical procedure within the body lumen. For example, in one embodiment,a balloon may be provided on the distal portion, and, in the secondposition, fluid delivered through the first lumen enters the ballooninterior to expand the balloon. Optionally, a spring element may beprovided within the balloon interior that provides sufficient bias toensure that the valve member substantially engages the tubular memberoutlet in the second position. Alternatively, the spring element mayhave sufficient bias such that, when the actuator is released afterdirecting the inner member to the first position, the spring elementautomatically directs the inner member towards the second position tosubstantially seal the outlet with the valve member.

If desired, the valve may be opened and fluid may be delivered throughthe outlet into the body lumen one or more times, e.g., whilemanipulating the apparatus, for example, to position the distal portionat a desired location, to observe the patient's anatomy, e.g., usingexternal imaging, and the like.

Once the distal portion is positioned at a desired location, one or moreprocedures may be performed within the body lumen. For example, thedistal portion may include one or more treatment elements for treatingthe body lumen. In one embodiment, the distal portion may carry aballoon in a contracted condition that has an interior communicatingwith one or more passages in the sealing member. For example, with thesealing member in the second position sealing the outlet, fluiddelivered through the first lumen may pass through the passage(s) intothe interior of the balloon, thereby expanding the balloon from thecontracted condition to an enlarged condition, e.g., for dilating alesion or otherwise treating a body lumen.

Optionally, the balloon may carry one or more therapeutic and/ordiagnostic agents, e.g., embedded within or otherwise carried on anouter surface of the balloon, which may pressed against the wall of thebody lumen. If desired, the balloon may include one or more features toenhance penetration into the wall of the body lumen, e.g., to enhancedelivery of the agent(s) into the wall.

In another option, the balloon may be directed to an expanded helicalshape within the body lumen, e.g., before or after expanding the balloonto the enlarged condition, and the balloon may be directed along a wallof the body lumen in the expanded helical shape to remove material fromthe wall of the body lumen.

In another embodiment, a prosthesis may be carried by the distalportion, e.g., over the balloon. For example, a stent, stent-graft,prosthetic valve, or other prosthesis, may be carried by the distalportion in a compressed state, and the balloon may be inflated to expandthe prosthesis within the body lumen, e.g., to dilate the body lumenand/or deploy the prosthesis within the body lumen.

In yet another embodiment, a self-expanding prosthesis may be carried onthe distal portion. In this embodiment, the distal portion may notinclude a balloon, but may include a removable constraint that mayoverly the prosthesis or otherwise maintain the prosthesis in acompressed state for delivery into the body lumen. Once the prosthesisis positioned at a desired location, e.g., after opening the valve anddelivering contrast or other fluid into the body lumen, the constraintmay be removed to allow the prosthesis to expand within the body lumen.Optionally, if a balloon is provided on the distal portion, the balloonmay be expanded, e.g., by delivering fluid through passage(s) in thesealing member from the first lumen with the inner member in the secondposition, to further expand the prosthesis, if desired.

In still another embodiment, the distal portion may include one or morepassages communicating between the sealing member and one or moreoutlets at a distal tip of the inner member. For example, with the valveopen in the first position, fluid delivered through the first lumen mayexit the outlet into the body lumen proximal to the distal portion. Withthe valve closed in the second position, fluid delivered through thefirst lumen may pass through the passage(s) in the distal portion andexit the outlet(s) into the body lumen distally beyond the distalportion. Thus, in this embodiment, contrast or other fluid may beselectively delivered on either side of the distal portion and/or atreatment element carried thereon during a procedure.

In accordance with yet another embodiment, a method is provided fortreating a body lumen of a patient using a balloon apparatus includingan outer member that includes a first lumen extending between a proximalend and an outlet on a distal end thereof, an inner member slidablewithin the first lumen, and a balloon attached to a distal end of theinner member beyond the outer member distal end. The distal end of theouter member may be introduced into a body lumen with the balloon in acontracted condition. The inner member may be directed between a firstposition wherein a sealing member on the inner member is spaced apartfrom the outlet, and a second position wherein the sealing membersubstantially seals an outlet in the outer member distal endcommunicating with the first lumen.

The inner member may be directed to the first or distal position, e.g.,using an actuator on a proximal end of the outer member, consequentlydirecting the sealing member away from and opening the outlet. Fluid maybe delivered through the first lumen such that the fluid passes throughthe outlet into the body lumen. Optionally, the inner member may bedirected to an intermediate position wherein some of the fluid isdelivered into the body lumen and some of the fluid passes through oneor more passages in the sealing member into the balloon interior to atleast partially expand the balloon.

If desired, the inner member may be directed towards the second orproximal position to substantially seal the outlet with the sealingmember, and fluid may be delivered through the first lumen with theoutlet substantially sealed, thereby delivering the fluid through theone or more passages in the sealing member to expand the balloon fromthe contracted condition to an enlarged condition. In exemplaryembodiments, the balloon may be used to dilate or otherwise treat a bodylumen, to deliver a prosthesis and/or one or more agents, and the like.After sufficient treatment, the fluid may be aspirated from the interiorof the balloon through the one or more passages and first lumen toreturn the balloon to the contracted condition.

Other aspects and features of the present invention will become apparentfrom consideration of the following description taken in conjunctionwith the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

It will be appreciated that the exemplary apparatus shown in thedrawings are not necessarily drawn to scale, with emphasis instead beingplaced on illustrating the various aspects and features of theillustrated embodiments.

FIG. 1 is a side view of a first exemplary embodiment of an apparatusincluding a balloon for treating a body lumen, the apparatus operable ina first mode for infusing fluid into the body lumen and a second modefor inflating the balloon and/or otherwise performing a procedure withinthe body lumen.

FIG. 2A is a side view of the apparatus of FIG. 1 in the first mode forinfusing fluid into a body lumen.

FIG. 2B is a side view of the apparatus of FIG. 1 in the second mode forinflating the balloon within a body lumen.

FIG. 3 is a perspective view of a distal end of another exemplaryembodiment of an apparatus for treating a body lumen.

FIG. 3A is a detail of an optional distal tip including a relativelyshort guidewire lumen, which may be provided on the apparatus of FIG. 3.

FIGS. 4A and 4B are details of the apparatus of FIG. 3 showing the valvein open and closed positions, respectively.

FIG. 4C is a cross-sectional view of the apparatus of FIGS. 3, 4A, and4B taken along line 4C-4C of FIG. 4B.

FIG. 5 is a cross-sectional view of an alternative embodiment of theapparatus of FIGS. 3 and 4A-4C.

FIG. 6 is a perspective view of a distal end of yet another exemplaryembodiment of an apparatus for treating a body lumen.

FIGS. 7A and 7B are side views of still another exemplary embodiment ofan apparatus operable in a first mode for infusing fluid into a bodylumen (FIG. 7A) and a second mode for delivering a prosthesis and/orperforming a procedure within the body lumen (FIG.

7B).

FIG. 7C is a side view of the apparatus of FIGS. 7A and 7B, showing aconstraint being advanced to deploy a prosthesis carried by theapparatus.

FIGS. 8A and 8B are side views of yet another exemplary embodiment of anapparatus operable in a first mode for infusing fluid into a body lumenproximal to a distal portion of the apparatus (FIG. 8A) and a secondmode for delivering fluid into the body lumen distal to the distalportion (FIG. 8B).

FIG. 9 is a side view of another embodiment of an apparatus including aballoon for treating a body lumen and a valve for selectively deliveringfluid from the apparatus.

FIGS. 10A and 10B are details of a distal end of the apparatus of FIG.9, showing the valve in open and closed positions, respectively.

FIG. 11 is a side view of a distal end of an alternative embodiment ofthe apparatus of FIG. 9, including a tensioning element for biasing theends of the balloon away from one another.

FIGS. 12A and 12B are side views of a distal end of another alternativeembodiment of the apparatus of FIG. 9, including a tensioning elementfor biasing the ends of the balloon away from one another, and showingthe valve in open and closed positions, respectively.

FIGS. 13A and 13B are details of a distal end of yet another alternativeembodiment of the apparatus of FIG. 9, showing a valve seal enhancingsealing of an outlet of the balloon.

FIGS. 14A-14C are cross-sectional views of alternative configurations ofinner and outer members that may be provided on any of the apparatusherein.

FIGS. 15A and 15B are side views of distal ends of alternativeembodiments of apparatus including a balloon and a valve memberpositionable at an intermediate condition in which fluid may be infusedinto a body lumen simultaneously with delivering fluid into the interiorof the balloon.

FIGS. 16A-16C are cross-sectional views of a body lumen within apatient's body showing different methods for treating a body lumen usingthe apparatus herein.

FIG. 17 is a side view of a distal end of yet another exemplaryembodiment of an apparatus for treating a body lumen.

FIGS. 18A-18C are side views of distal ends of alternative embodimentsof the apparatus of FIG. 17.

FIGS. 19A and 19B are side views of a distal end of an exemplaryembodiment of an introducer sheath including a balloon and sealingmember.

FIGS. 20A and 20B are side and top views, respectively, of anotherexemplary embodiment of an apparatus including an integrated inflationdevice.

FIGS. 21A and 21B are side views of still another exemplary embodimentof an apparatus for treating a body lumen including a rotatable curveddistal tip, showing the distal tip in first and second orientations.

FIG. 21C is a side view of the apparatus of FIGS. 21A and 21B, showing aguidewire introduced through the apparatus to substantially straightenthe distal tip.

FIGS. 22A and 22B are side views of the apparatus of FIGS. 21A-21C,showing a valve thereof in closed and open positions, respectively.

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

Turning to the drawings, FIGS. 1-2B show a first exemplary embodiment ofan apparatus 10 for treating a body lumen, e.g., for infusing fluid intoa body lumen, such as a blood vessel, aorto-venous fistula, tubulargraft, and the like (not shown), and/or for performing a procedurewithin the body lumen, e.g., dilating a stenosis or other obstructionwithin the body lumen, removing thrombus, objects, and/or obstructivematerial from within the body lumen, delivering a stent, stent-graft,prosthetic valve, or other prosthesis (also not shown), delivering oneor more agents into the body lumen, and the like. Generally, theapparatus 10 includes a catheter, sheath, or other tubular outer member20, a shaft or other elongate inner member 30, and an expandable balloonor other treatment element 50 carried by the inner and/or outer members20, 30, e.g., on a distal portion 48 of the inner member 30 shown inFIG. 1.

The apparatus 10 may be operable in multiple modes, for example, toperform various treatments or other functions within a body lumen, e.g.,to reduce or eliminate the need to exchange multiple devices during aprocedure within a body lumen. For example, the apparatus 10 may includea valve, e.g., including a sealing or valve member 38, operable in afirst mode for infusing fluid into a body lumen (FIG. 2A), and a secondmode to facilitate introduction into a patient's body and/or to inflatethe balloon 50 (FIG. 2B), as described further below.

As best seen in FIG. 1, the outer member 20 includes a proximal end 22coupled to a handle 60, a distal end 24 sized for introduction into abody lumen, and a first lumen 26 extending between the proximal end 22and an outlet 27 in the distal end 24. The outer member 20 may have asubstantially uniform construction along its length, or alternatively,the construction may be varied. For example, a proximal portion of theouter member 20 may be substantially rigid or semi-rigid to facilitateadvancement of the apparatus 10 from the proximal end 22, and/or adistal portion of the outer member 20 may be flexible, e.g., tofacilitate bending and/or advancement through tortuous anatomy withoutsubstantial risk of kinking or buckling. In exemplary embodiments, theouter member 20 may be formed from one or more materials such as metal,plastic, e.g., PEEK, Grilamed L25, and the like, or composite materials.The outer member 20 may have a length between about thirty and onehundred thirty centimeters (30-130 cm) and an outer diameter betweenabout 1.2 and 2.0 millimeters, and the first lumen 26 may have adiameter between about 1.0 and 1.8 millimeters.

The inner member 30 also includes a proximal end (not shown), a distalend 34, and, optionally, may include a second lumen 36 extending betweenthe proximal end and a distal tip 35, which may be sized to slidablyreceive a guide wire, or other rail (not shown) therethrough, e.g.,having a diameter between about 0.3 and 1.0 millimeter. Alternatively,as shown in FIG. 3A, a distal tip 35″ may be provided on the apparatus10″ (or any of the other embodiments herein) that includes a relativelyshort guidewire lumen 36″ beyond the balloon 50″. As shown, theguidewire lumen 36″ may communicate between a distal port 36 a″ in thedistal tip 35″ and a proximal side port 36 b″ adjacent to the distal end54″ of the balloon 50″. In this alternative, a guidewire (not shown) maybe backloaded into the distal port 36 a″ through the guidewire lumen 36″and out the proximal port 36 b″, e.g., to provide a “rapid-exchange”lumen such that the guidewire need not be loaded through the entirelength of the inner member 30″. Thus, in this alternative, the secondlumen 36 (shown in FIGS. 1-2B) may be omitted.

The inner member 30 may have a substantially uniform construction alongits length, or alternatively, the construction may be varied, similar tothe outer member 20. For example, the inner member 30 may be formed froma composite construction including a braided, helical, or other supportstructure, e.g., formed from metal, such as stainless steel, polymericstrong fiber, and the like, embedded in a polymeric matrix, e.g., athermoset polymeric matrix, such as polyimide, that may resist the innermember 30 taking a shape set when bent or curved. Optionally, the innermember 30 may include a tether wire 31 coupled between the proximal anddistal ends 32, 34, e.g., bonded or otherwise attached to the valvemember 38 and/or balloon 50, as shown in FIGS. 2A and 2B. The tetherwire 31 may be embedded in the shaft of the inner member 30 or may befree and/or external to the shaft other than at the valve member 38and/or balloon 50, as shown. The tether wire 31 may be a high strength,relatively small cross-section wire or filament that may provide asafety feature to prevent the balloon 50 from becoming loose from theapparatus 10, e.g., if the inner member 30 were somehow broken betweenthe proximal and distal ends 32, 34 during use.

Returning to FIG. 1, the inner member 30 is sized to be slidablyreceived within the first lumen 26 of the outer member 20, e.g., suchthat an annular space is defined between the outer and inner members 20,30 for passing one or more fluids therethrough, as described furtherbelow. The inner member 30 may have a length relative to the outermember 20 such that the inner member proximal end is received within orextends proximally beyond the outer member proximal end 22, e.g., intothe handle 60, and the inner member distal end 34 extends distallybeyond the outlet 27 of the outer member 20, e.g., to define the distalportion 48, as described further below. The distal tip 35 may have arounded, tapered, and/or other shape, e.g., to provide a substantiallyatraumatic tip for the apparatus 10, similar to embodiments in theapplications incorporated by reference herein.

The handle 60 may be coupled to or otherwise provided on the proximalend 22 of the outer member 20, e.g., attached by one or more of aninterference fit, bonding with adhesive, sonic welding, cooperatingconnectors (not shown), and the like. An actuator 60 may be coupled tothe proximal end of the inner member 30 for directing the inner member30 axially relative to the outer member 20, e.g., to open or close theoutlet 27 and/or to direct the apparatus 10 between the different modes,as described further elsewhere herein. The handle 60 may also includeone or more ports 64, e.g., a first port 64 a communicating with thefirst lumen 26, and a second port 64 b communicating with the secondlumen 36, similar to embodiments in the applications incorporated byreference herein.

The balloon 50 includes proximal and distal ends 52, 54 coupled to thedistal portion 48 of the inner member 30, e.g., a distal end 54 attachedto the inner member 30, e.g., adjacent the distal tip 35, a proximal end52 attached to the distal end 34 of the inner member 30 proximal to thedistal tip 35, thereby defining a substantially fluid-tight interior 56.For example, the distal end 54 of the balloon 50 may be attached orotherwise secured directly to the distal end 24 of the outer member 20and/or to the distal tip 35 to provide a fluid-tight connection, e.g.,by one or more of bonding with adhesive, interference fit, sonicwelding, fusing, engagement with a surrounding sleeve or other connector(not shown), and the like.

The balloon 50 may be formed from elastic material, e.g., to provide acompliant or semi-compliant balloon that may be expanded to a variety ofsizes and/or shapes, e.g., based on the amount of fluid and/or pressurewithin the interior 56. Alternatively, the balloon 50 may be formed fromsubstantially inelastic material, e.g., to provide a non-compliantballoon that expands to a predetermined size when inflated substantiallyindependent of pressure (once a minimum volume and/or pressure isintroduced to achieve the predetermined size). Such a non-compliantballoon 50 may expand to the predetermined size even if inflated torelatively high pressures, e.g., until the balloon 50 bursts orotherwise ruptures, e.g., at pressures of at least ten atmospheres,twenty atmospheres, thirty atmospheres, and the like.

As best seen in FIGS. 2A and 2B, the sealing or valve member 38 isprovided on or adjacent the distal portion 48 of the inner member 32,e.g., adjacent the proximal end 52 of the balloon 50. For example, thesealing member 38 may be attached to an outer surface of the innermember 30 and the proximal end 52 of the balloon 50 may be attached tothe sealing member 38. As shown, the proximal end 52 of the balloon 50extends at least partially over the sealing member 38 and may beattached to the sealing member 38, e.g., by bonding with adhesive, sonicwelding, fusing, interference fit, an exterior collar (not shown), andthe like. Thus, the proximal end 52 of the balloon 50 may have asubstantially fluid-tight seal with the sealing member 38 andconsequently the inner member 30.

The sealing member 38 generally has a size to at least partially enterthe first lumen 26 of the outer member 20, e.g., such that the sealingmember 38 may substantially seal the outlet 27 when the sealing member38 is engaged with or received in the outlet 27 and/or first lumen 26.For example, as best seen in FIG. 2B, the sealing member 38 may includea valve body 38 a and one or more annular valve seals 38 b extendingaround the valve body 38 a. Although only a single valve seal 38 b isshown, it will be appreciated that a plurality of valve seals (notshown) may be provided that are spaced apart axially from one anotheralong a length of the valve body 38 a, e.g., to enhance the resultingseal.

The valve body 38 a may have an outer diameter slightly smaller than theinner diameter of the first lumen 26 and/or outlet 27, e.g., such thatthe valve body 38 a may freely enter the first lumen 26 through theoutlet 27. The valve seal(s) 38 b may have an outer diameter that isslightly larger than the inner diameter of the first lumen 26 such thatthe valve seal(s) 38 b slidably engage the inner surface of the outermember 20 when the valve body 38 a enters the first lumen 26. Forexample, the valve seal(s) 38 b may be formed from resiliently flexiblematerial, such as silicone or other elastomer, a low Durometer (e.g., 40D) PEBAX material, polyurethane, and the like, that may be sufficientlycompressible to accommodate sliding into the first lumen 26 withoutcreating substantial friction, yet may resist deformation undersubstantial fluid pressure, e.g., to maintain a substantiallyfluid-tight seal against the inner wall of the outer member 20.

Alternatively, the valve seal(s) 38 b may be formed from relativelyharder, lubricious material that has mechanical compressibility, e.g.,polyethylene tubular or other hollow structure that may bend in responseto applied loads. The valve body 38 a may be formed from a differentmaterial than the valve seal(s) 38 b, e.g., to provide a more rigid baseor support for the valve seal(s) 38 a, or may be formed from the samematerial, e.g., integrally molded, or otherwise formed from a singlepiece of material. Thus, the valve seal(s) 38 b may slidably engage theinner surface of the outer member 20 to provide a substantiallyfluid-tight seal without requiring excessive force that may otherwisejam or damage the apparatus 10 during use.

Optionally, the sealing member 38 may have a tapered shape to facilitatealigning and/or receiving the sealing member 38 within the outlet 27.For example, as shown in FIGS. 2A and 2B, the valve body 38 a mayinclude a tapered proximal end 38 c to guide the sealing member 38 intothe outlet 27 and first lumen 26, e.g., in case the outer and innermembers 20, 30 become out of concentric alignment with one anotherduring use.

Alternatively, as shown in FIGS. 3-4C, a sealing member 38′ may beprovided that has an outer diameter that is larger than the innerdiameter of the outlet 27′. In this alternative, the sealing member 38′may also include a tapered proximal end 38 c′, e.g., to facilitate thesealing member 38′ engaging or being received at least partially withinthe outlet 27′ of the outer member 20′. Thus, only the tapered proximalend 38 c′ may be received within the outlet 27′ until the largermidsection of the sealing member 38′ abuts the distal end 24′ of theouter member 20′ to provide a substantially fluid-tight seal.

As best seen in FIGS. 2A and 2B, the sealing member 38 may include oneor more passages 39 extending generally longitudinally between theproximal end 38 c and a distal end 38 d of the sealing member 38, e.g.,a plurality of enclosed passages or grooves formed in the valve body 38a. For example, the valve body 38 a may be formed as an extrusionincluding a bore for receiving the inner member 30 and one or moreenclosed passages 39 extending between the ends 38 c, 38 d.Alternatively, enclosed lumens may be formed within the wall of thetubing to provide the passage(s) 39 using other methods. In a furtheralternative, shown in FIGS. 3-4C, the sealing member 38′ may be providedas a length of tubing with one or more longitudinal grooves formed in aninner surface thereof. When the sealing member 38′ is attached to orotherwise placed around the inner member 30′, the groove(s) may extendalong the outer wall of the inner member 30′, thereby together definingthe passage(s) 39′.

In addition or alternatively, if desired, the apparatus 10 may includeone or more markers to facilitate positioning and/or advancement of theapparatus 10 during use. For example, as best seen in FIG. 1, radiopaquemarkers 29 may be provided on the distal portion 48 of the inner member30, e.g., aligned with or adjacent the proximal and distal ends 52, 54of the balloon 50. In addition or alternatively, one or more radiopaquemarkers (not shown) may be provided on the outer member distal end 24,on the distal tip 35, on the balloon 50, e.g., on the proximal and/ordistal ends 52, 54, and/or on the sealing member(s) 38. Alternatively,one or more components of the apparatus 10 may be formed from radiopaqueor other materials that may facilitate imaging the apparatus 10 duringuse. For example, radiopaque markers and/or materials may facilitatepositioning or otherwise imaging the apparatus 10 using fluoroscopy orother x-ray imaging, e.g., when positioning the balloon 50 (eitherbefore or after expansion) and/or when infusing fluid via the outlet 27.Alternatively, echogenic markers and/or materials may be provided tofacilitate imaging using ultrasound or similar imaging techniques.

Returning to FIGS. 1-2B, during assembly, the sealing member 38 may beplaced around the inner member 30 at the desired location on the distalend 34, e.g., proximal to the desired length for the distal portion 48and attached thereto, e.g., by bonding with adhesive, sonic welding,fusing, heat shrinking, and the like. The proximal end 52 of the balloon50 may then be positioned partially over the sealing member 38 andattached thereto. Thus, the passage(s) 39 may communicate from theoutside of the proximal end 38 c of the sealing member 38 with theinterior 56 of the balloon 50. The distal tip 35 may be attached to theinner member 30, e.g., by an interference fit, bonding with adhesive,cooperating connectors, sonic welding, fusing, and the like. The distalend 54 of the balloon 50 may be attached to the distal end 34 of theinner member 30, e.g., closer to or over the distal tip 35.Consequently, the interior 56 of the balloon 50 may be substantiallysealed other than the passage(s) 39 through the sealing member 38.

With additional reference to FIG. 1, the outer member 20 may bepositioned around the inner member 30 and the handle 60 and actuator 62may be coupled to the outer and inner members 20, 30, respectively,e.g., similar to embodiments disclosed in the applications incorporatedby reference herein. The apparatus 10 may be operable in a first modefor delivering fluid into a body lumen (not shown) into which theapparatus 1010 is introduced (or otherwise exterior to the distal end 24of the outer member 20) and a second mode for inflating the balloon 50.

For example, the inner member 30 may be movable between a first ordistal position, shown in FIG. 2A, where the sealing member 38 is spacedapart from the outlet 27 of the outer member 20, and a second orproximal position, shown in FIG. 2B, where the sealing member 38 atleast partially enters the outlet 27 and first lumen 26. In the firstposition, fluid delivered through the lumen 26 of the outer member 20may exit the outlet 27 and enter the body lumen or other exteriorenvironment, e.g., proximal to the distal portion 48. In the secondposition, the valve seal(s) 38 b may substantially seal the outlet 27such that fluid delivered through the lumen 26 may enter through thepassage(s) 39 in the sealing member 38 and into the interior 56 of theballoon 50, thereby inflating the balloon 50. In addition, in the secondposition, a vacuum may be applied to the first lumen 26 to aspirateinflation media from the interior 56, e.g., to collapse the balloon 50when desired.

Turning to FIG. 5, an alternative embodiment of the apparatus 110 isshown similar to the apparatus 10, 10′ described above. The apparatus110 includes an outer member 120, an inner member 130, a balloon 150,and a sealing member 138 similar to the apparatus 10, 10′. The apparatus110 may be operable in first and second modes by directing the innermember 130 between a first or distal position and a second or proximalposition, also similar to the apparatus 10, 10′.

However, unlike the previous embodiments, the apparatus 110 includes aspring or other biasing mechanism 190 coupled between the inner andouter members 130, 120 for biasing the inner member 130 to one of thefirst and second positions. For example, as shown, the spring 190 maybias the inner member 130 towards the proximal position, i.e., such thatthe outlet 127 of the apparatus 110 is normally closed and/or to enhancesealing the outlet 127 with the sealing member 138. The bias may beovercome by directing the inner member 130 distally to unseat thesealing member 138 and open the outlet 127.

As shown, the spring 190 includes a first end 192 attached or otherwisecoupled to the distal end 124 of the outer member 120, and a second end194 attached or otherwise coupled to the distal end 134 of the innermember 130 and/or the sealing member 138. For example, the second end194 of the spring 190 may be attached between the sealing member 138 andthe inner member 130 or otherwise to the sealing member 138, while stillaccommodating the passage 139 extending through the sealing member 138.In exemplary embodiments, the ends 192, 194 of the spring 190 may beattached to the inner and outer members 130, 120 by bonding withadhesive, sonic welding, fusing, interference fit, one or moreconnectors (not shown), and the like.

The relative diameter of the spring 190 and the inner member 130 may beset to reduce the risk of over-extension of the spring 190. For example,the spring 190 may be relaxed or under slight tension when the innermember 130 is in the proximal position and may be placed under highertension when the inner member 130 is directed distally. As the spring190 is placed under higher tension, the diameter of the spring 190 maydecrease thereby increasing friction between the spring 190 and theinner member 130. This increasing friction may reduce the risk ofover-extending the spring 190, which may otherwise plastically deformthe spring 190 or otherwise prevent the spring 190 from subsequentlybiasing the inner member 130 proximally towards the proximal position.

Turning to FIG. 6, yet another alternative embodiment of the apparatus110′ is shown similar to the apparatus 110 of FIG. 5. The apparatus 110′includes an outer member 120′, an inner member 130′, a balloon 150′, asealing member 138′, and a spring 190′, similar to the apparatus 110.The apparatus 110′ may be operable in first and second modes bydirecting the inner member 130′ between a first or distal position and asecond or proximal position, also similar to the apparatus 10, 10′.

In addition, the apparatus 110′ includes a helical member 170′ withinthe balloon 150′ that may be expanded to an expanded helical shape,similar to embodiments in the applications incorporated by referenceherein. For example, the helical member 170′ may include a first orproximal end coupled to the outer member 120′ (not shown) and a secondor distal end 174′ coupled to the inner member 130′, adjacent the distalend 154′ of the balloon 150′. Thus, the apparatus 110′ may also beoperated in a third mode, e.g., by directing the inner member 130′proximally from the second position to a third position in which thehelical member 170′ is axially compressed and radially expanded. Theballoon 150′ may remain collapsed while the helical member 170′ isexpanded or may be inflated and then collapsed after the helical member170′ is expanded, similar to embodiments in the applicationsincorporated by reference herein.

After the helical member 170′ and balloon 150′ are used to removematerial in the expanded helical shape, the inner member 130′ may bedirected distally to return the helical member 170′ to its originalcontracted shape around the inner member 130′. This action may extendthe spring 190′ and open the outlet 127′. However, as discussed above,the relative sizes of the spring 190′ and the inner member 130′ may besuch that the spring 190′ compresses as it extends and frictionallyengages the inner member 130′, thereby reducing the risk of the spring190′ over-extending while the inner member 130′ is directed distally.

Turning to FIGS. 21A-22B, another embodiment of an apparatus 810 isshown, which may be similar to the apparatus 10, 10′ described above (orone or more of features of the apparatus 810 may be incorporated intoany of the embodiments described herein or in the applicationsincorporated by reference herein). The apparatus 810 generally includesan outer member 820 including proximal and distal ends 822, 824, aninner member 830 including proximal and distal ends 832, 834, a balloon850 including proximal and distal ends 852, 854, and a sealing member838 similar to the apparatus 10, 10′.

The apparatus 810 also includes a flexible distal tip 835 extending fromthe distal end 834 of the inner member 830 that has a “J” tip or othercurved shape. Optionally, the distal tip 835 may have a tapered shapethat narrows distally from the balloon 850 or may have a substantiallyuniform cross-section (not shown), if desired. The distal tip 835 may bebiased to the curved shape yet may be resiliently flexible such that thedistal tip 835 may be at least partially straightened, e.g., bydirecting a guidewire or other rail 99 having greater rigidity than thedistal tip 835 through the distal tip 835, as shown in FIG. 21C. Thus,with the guidewire 99 removed from the distal tip 835, the distal tip835 may resiliently adopt its curved shape, as shown in FIGS. 21A and21B, e.g., to facilitate advancement of the apparatus 810 through apatient's body. However, if desired, the distal tip 835 may bestraightened, e.g., by introducing the guidewire 99 therethrough, toaccommodate advancing the apparatus 810 over the guidewire 99, as shownin FIG. 21C.

The apparatus 810 may be operable in first and second modes by directingthe inner member 830 between a first or distal position where the valveis open (see FIG. 22A), and a second or proximal position (see FIG. 22B)where the valve is closed, similar to other embodiments herein. Forexample, a handle 860 may be provided on the proximal end 822 of theouter member, and an actuator 862 may be coupled to the proximal end 832of the inner member 830, similar to other embodiments herein. Theactuator 862 may be movable axially, i.e., proximally and distallyrelative to the handle 860 for directing the inner member 830 betweenthe proximal and distal positions.

In addition, unlike the previous embodiments, the actuator 862 and innermember 830 may be rotatable about a longitudinal axis of the apparatus810. Thus, the actuator 862 may be rotated relative to the handle 860 torotate the inner member 830 and thereby change the orientation of thecurved distal tip 835. For example, FIGS. 21A and 21B show the curveddistal tip 835 in opposite orientations, which may be achieved byrotating the actuator 862 about one hundred eighty degrees (180°)relative to the handle 860. Thus, rather than rotating the entireapparatus 810, i.e., including both the outer and inner members 820, 830to change the orientation of the distal tip 835, only the inner member830 need be rotated. If the entire apparatus 810 were rotated, the outermember 820 may become twisted or otherwise fail to transmit substantialtorque between its proximal and distal ends 822, 824, e.g., if the outermember 820 is formed from polymeric material having poor torquetransmission. Instead, the inner member 830 may be decoupled from theouter member 820, i.e., freely rotatable therein, thereby facilitatingtransmitting torque freely between the proximal and distal ends 832,834.

To facilitate transmission of such rotation between the proximal anddistal ends 832, 834 of the inner member 830, the shaft of the innermember 830 may be formed from a composite or other construction thatresists twisting. For example, the inner member 830 may be formed from astainless steel (or other metal or polymeric strong fiber) braid in apolymeric matrix (e.g., a thermoset polymeric matrix, such as polyimide,that resists the inner member 830 taking a shape set when bent orcurved). Such construction may provide good flexibility while alsomaintaining substantial torque transmission between the proximal anddistal ends 832, 834.

The actuator 862 may be freely rotatable relative to the handle 860, ifdesired. Alternatively, cooperating features (not shown) may beprovided, e.g., on the handle 860 and inner member 830, to limitrotation of the actuator 862 and inner member 830. For example, one ormore detents or tracks (not shown) may be provided within the handle 860and/or on the proximal end 832 of the inner member 830 that interact tolimit rotation to less than three hundred sixty degrees (360°). Thus, auser may be able to rotate the actuator 862 to change the orientation ofthe curved distal tip 835 close to a complete rotation, while limitingexcessive rotation in one direction, which may otherwise apply excessivetorque on the inner member 830.

To allow rotation of the inner member 830 relative to the outer member820, the actuator 862 may be directed to the first position, therebyopening the valve and decoupling the distal end 824 of the outer member820 from the sealing member 838 and, consequently, from the inner member830. In the first position, the inner member 830 may be rotated relativeto outer member 820 to change the orientation of the distal tip 835.

Optionally, the sealing member 838 and/or outer member 820 may beconstructed to minimize friction therebetween, e.g., to allow rotationof the inner member 830 in the second position with the valve closed. Inthis option, materials having a relatively low coefficient of friction,e.g., PTFE, polyethylene, and the like, may be provided, e.g., on theouter surface of the sealing member 838 and/or on the inner surface ofthe distal end 824 of the outer member 820. Thus, rather than having toopen the valve to decouple the outer and inner members 820, 830, themembers may freely rotate relative to one another even with the valveclosed.

Returning to FIGS. 1-2B, the apparatus 10 (or any of the embodimentsherein) may be introduced into a body lumen (not shown), e.g., via apatient's vasculature or other natural or surgically created passages,to perform one or more therapeutic and/or diagnostic medical procedures.In an exemplary embodiment, the target body lumen may be a blood vessel,e.g., a vein or artery, a graft, e.g., an aorto-venous fistula, tubularxenograft, or synthetic tubular graft, and the like. For example, thebody lumen may be a passage communicating between an adjacent artery andvein (not shown), e.g., in an arm or other region of a dialysis patient.Alternatively, the body lumen may be a blood vessel within a patient'svasculature, e.g., a peripheral vessel in a patient's leg, a cerebralvessel, and the like. In a further alternative, the material may be astone within a patient's urinary tract or other foreign object to beremoved from the patient's body. In yet another alternative, the bodylumen may be an aorta or a chamber of a heart, e.g., the site of a heartvalve in need of repair, replacement, or other treatment.

Optionally, the body lumen may be accessed using one or more additionalinstruments (not shown), which may be part of a system or kit includingthe apparatus 10. For example, an introducer sheath, guide catheter, orother tubular member (not shown) may be introduced adjacent the targettreatment site where material is to be removed, or may be introducedelsewhere in the patient's body to provide access to the patient'svasculature or other passages communicating with the body lumen. If thebody lumen is located in a peripheral vessel of the patient'svasculature, a percutaneous puncture or cut-down may be created using aneedle or other instrument (not shown) at a peripheral location, such asa femoral artery, carotid artery, or other entry site (also not shown),and an introducer sheath may be placed through the puncture at theperipheral location to provide access. The apparatus 10 may be advancedthrough the patient's vasculature from the entry site, e.g., alone orwith the aid of a guide catheter, guidewire, and the like (not shown).

For example, to facilitate directing the apparatus 10 from an entry siteto the target body lumen, a guide catheter, micro-catheter, or othertubular body may be placed from the entry site to the body lumen usingconventional methods. In addition or alternatively, a guidewire (notshown) may be placed from the entry site to the body lumen if desired,e.g., if the inner member 30 includes the second lumen 36.Alternatively, if the apparatus 10 includes a rapid-exchange guidewirelumen in its distal tip, the guidewire may be backloaded through thedistal tip to facilitate advancing the apparatus 10 along the guidewire.Optionally, the guide catheter or tubular body may also be used foraspiration, e.g., coupled to a source of vacuum for capturing materialremoved by the apparatus 10, as described further below and in theapplications incorporated by reference herein.

Initially, with reference to FIG. 2A, the apparatus 10 may be providedwith the inner member 30 in the second position and the sealing member38 substantially sealing the outlet 27. In this position, the sealingmember 38 may also provide a substantially smooth transition for thedistal end 24 of the outer member 20 (in addition to sealing the outlet27), e.g., which may facilitate advancement of the apparatus 10 withminimal risk of damaging the walls of body lumens, e.g., when theapparatus 10 is advanced through tortuous anatomy. Alternatively, theapparatus 10 may be introduced with the inner member 30 in the firstposition, i.e., with the outlet 27 open, if desired, to facilitatedelivery of fluids during manipulation of the apparatus 10.

If the apparatus 10 includes a curved distal tip (not shown), e.g.,similar to the apparatus 810 shown in FIGS. 21A-22B, the distal tip maybe straightened during advancement over a guidewire or other rail. Ifdesired to deploy the distal tip in its curved shape, the guidewire maybe withdrawn partially until removed from the distal tip, whereupon thedistal tip may resiliently return to its curved shape. The curved tipmay then be rotated, e.g., by rotating the inner member if the innermember is rotatable independent of the outer member or the entireapparatus 10, to access a branch or otherwise facilitate advancement ofthe apparatus 10 from one body lumen into another. For example, once thecurved tip is rotated and the apparatus manipulated sufficiently withina body lumen, e.g., to advance the distal tip into a branch adjacent thebody lumen, the guidewire may be advanced again to straighten the distaltip and advance the guidewire before advancing the apparatus 10 further.

At any time, if it is desired to deliver fluid into the body lumen, theinner member 30 may be directed to (if not already in) the distal orfirst position to space the sealing member 38 from the distal end 24 ofthe outer member 20 and open the outlet 27 (FIG. 2A). Fluid may then bedelivered through the lumen 26 of the outer member and out the outlet 27into the body lumen. Because the outlet 27 is spaced away from thesealing member 38, substantially all of the fluid is injected into thebody lumen and does not pass through the passage(s) 39 into the balloon50.

For example, radiopaque contrast or other fluid may be delivered intothe body lumen via the annular passage defined by the first lumen 26between the outer and inner members 20, 30 to facilitate monitoringand/or identifying the location of the distal portion 48 and/or a targettreatment site. Markers 29 (and/or other markers, not shown) on theapparatus 10 may facilitate positioning the balloon 50 relative to thetreatment site. For example, contrast may facilitate identifyingobstructive material intended to be dilated or removed within a bodylumen, an implantation site for a prosthesis, and the like before theballoon 50 is expanded, e.g., to facilitate verifying that the balloon50 is positioned within or adjacent the treatment site.

As best seen in FIG. 2B, when it is desired to expand the balloon 50(and/or otherwise perform a procedure involving another treatmentelement, not shown, on the distal portion 48), the inner member 30 maybe directed to (or may be automatically biased to) the proximal orsecond position, e.g., to substantially seal the outlet 27 with thesealing member 38 (FIG. 2B). The sealing member 38 may provide asubstantially fluid-tight seal of the outlet 27 such that subsequentfluid delivery through the first lumen 26 causes the fluid to passthrough the passage(s) 39 of the sealing member 38 into the interior 56of the balloon 50, thereby inflating the balloon 50.

For example, during an exemplary procedure, the apparatus 10 may bepositioned until the distal portion 48 and balloon 50 are positioneddistally beyond an obstructed region within a body lumen. With the innermember 30 in the second position sealing the outlet 27, the balloon 50may be inflated within the body lumen, e.g., such that the balloon 50extends substantially entirely across the body lumen. The entireapparatus 10 may then be retracted to pull the material from the bodylumen, e.g., to be aspirated into a guide catheter (not shown), orotherwise removed from the body lumen. Optionally, the balloon 50 may bedirectable to a helical configuration, similar to the apparatus in theapplications incorporated by reference herein, e.g., to facilitateremoval of material within the body lumen.

Once material is removed, the inner member 30 may be directed backtowards the second position, and fluid may be introduced through theoutlet 27 to observe the amount of material removed and/or remainingwithin the body lumen. If additional material is to be removed, theinner member 30 may be directed to the first position, e.g., if desiredto advance the apparatus 10 through additional material to be removed.Once the balloon 50 is located beyond the material, the process may berepeated as often as desired with the valve opened and closed to monitorthe position of the balloon 50 and/or progress of removal.

In addition, if desired, the obstructive material may be treated, e.g.,at least partially dissolved, macerated, and the like before, during, orafter withdrawal. For example, a therapeutic agent may be delivered intothe body lumen via the first lumen 26 and outlet 27 of the outer member20, e.g., to at least partially dissolve or separate thrombus or otherrelatively soft material before being removed by the balloon 50 and/orotherwise to treat the wall of the body lumen.

To collapse the balloon 50, e.g., after inflating the balloon 50 toremove material, dilate an obstruction, and/or otherwise treat a bodylumen, fluid may be evacuated from the interior 56 through thepassage(s) 39 and the first lumen 26. Alternatively, the inner member 30may be directed towards the first position to disengage the sealingmember 38 and open the outlet 27. The fluid within the balloon 50 maythen be free to escape through the passage(s) 39 into the body lumen anddeflate the balloon 50 without requiring aspiration.

Optionally, if desired, the inner member 30 may be positioned at anintermediate position, i.e., between the first and second positions,e.g., as shown in FIG. 15B, in which fluid delivered from the outlet 27may be divided such that some fluid enters the passage(s) 39 and expandsthe balloon 50 while the remaining fluid is delivered into the bodylumen, as described further below. The relative amount of inflation andfluid delivery into the body lumen may be adjusted, as desired, simplyby directing the inner member 30 proximally or distally to move thesealing member 38 closer to or further from the outlet 27. Thisprocedure may be accomplished using external imaging, e.g., if the fluidincludes radiopaque contrast, to monitor the inflation and/or positionof the balloon 50 and/or the surrounding vasculature within which theballoon 50 is located.

In another option, the apparatus 10 may be used to deliver and aspiratefluid using the outlet 27. For example, a user may want to deliver andremove one or more diagnostic and/or therapeutic agents within a bodylumen using the apparatus 10. In one example, contrast, dyes, or othermaterial for facilitating imaging may be delivered into the body lumenfrom the outlet 27 (with the inner member 30 and sealing member 38 inthe first position) and then aspirated back into the outlet 27 to reducethe amount of contrast that remains within the body lumen or travels toother locations in the patient's body. In addition or alternatively, theouter member 20 may include one or more additional lumens (not shown,see, e.g., FIG. 14B) extending between the proximal and distal ends 22,24, if desired, e.g., for delivering and/or aspirating materialinto/from an exterior environment adjacent the distal end 24.

In another example, a lytic agent may be delivered into the body lumen,e.g., to break up clot or other material within the body lumen, and thenloose material may then be aspirated into the outlet 27 and through thelumen 26 (or into a guide catheter, not shown, positioned over theapparatus 10), which may reduce the risk of bleeding or otherwiseexposing the lytic agent systemically to the patient's body. The outlet27 may also be used to aspirate pieces of thrombus or other materialthat is not dissolved or broken down by the agent and/or is otherwiseloosened within the body lumen. During such procedures, the balloon 50may be at least partially inflated, e.g., by directing the inner member30 to an intermediate position, as shown in FIG. 15B, to stop or reduceflow through the body lumen while the one or more agents are deliveredand aspirated, which may also reduce exposure of other locations to theagent(s) delivered into the body lumen.

With the apparatus 10 and procedures described herein, the first lumen26 may be used for both inflation of the balloon 50 and delivering fluidinto the body lumen. Thus, the profile of the outer member 20 andtherefore of the overall apparatus 10 may be smaller than devices thatinclude separate inflation and infusion lumens. Further, although thesecond lumen 36 of the inner member 30 could be used for infusion offluids, this would generally require removing the guidewire over whichthe apparatus 10 is introduced since the guidewire may substantiallyfill the second lumen 36. Because the first lumen 26 may be used forinfusion, the guidewire may remain within the second lumen 36 throughoutthe procedure, thereby potentially reducing the number of guidewire orother device exchanges. Further, the apparatus 10 may remain over theguidewire, which may facilitate advancing the apparatus 10 to othertarget body lumens intended for treatment, as explained in theapplications incorporated by reference herein.

Turning to FIG. 16A, in another exemplary method, the body lumen 90 mayinclude an occlusion 94, e.g., a partial or chronic total occlusionwithin a blood vessel, and the apparatus 10 may be introduced to dilateand/or otherwise treat the occlusion 94. As shown, a guidewire 99 hasbeen tracked from an entry site (not shown) into the body lumen 90 andthrough the occlusion 94, e.g., using known methods. Chronic totallesions may be particularly difficult to treat because there is littleopportunity to perform conventional dye injections to facilitate imagingsince there is no flow through the body lumen 90. Further, it may bedifficult to track and/or position the guidewire 99 and/or apparatus 10within the body lumen 90 without using dye injections.

Initially, the apparatus 10 may be advanced into the body lumen 90 withthe balloon 50 in its collapsed condition. For example, the apparatus 10may be advanced over the guidewire 99 previously placed through theocclusion 94, e.g., until the distal end 54 of the balloon 50 enters theregion of the body lumen 90 beyond the occlusion 94, as shown. With theballoon 50 positioned at least partially within the occlusion 94, theinner member 30 may be directed to open the outlet 27, and radiopaquecontrast, dye, or other fluid (represented by 95) may be delivered intothe body lumen 90 via the annular passage defined by the first lumen 26between the outer and inner members 20, 30 to facilitate locating and/ormeasuring the size of the material of the occlusion 94 and/or body lumen90, e.g., using fluoroscopy. Markers 29 (not shown in FIG. 16A, seeFIG. 1) on the apparatus 10 may facilitate positioning the balloon 50relative to the occlusion 94 before the balloon 50 is expanded, e.g., tofacilitate verifying that the balloon 50 is positioned through and/oracross the occlusion 94. If desired, the inner member 30 may be directedback and forth between the first and second positions, e.g., to allowinfusion of contrast and inflation of the balloon 50 to dilate theocclusion 94 and monitor the progress of the treatment.

Thus, the apparatus 10 may facilitate dye injection adjacent theocclusion 94 while maintaining the guidewire 99 in position. Unlike theapparatus 10, conventional devices may require removing a guidewire orother device advanced through the occlusion 94 to allow dye injectionsand imaging around the occlusion 94. In such procedures, it may bedifficult to reintroduce the guidewire or other device back through thesmall passage created through the occlusion 94.

If desired, obstructive material may be treated, e.g., at leastpartially dissolved, macerated, and the like before, during, or afterwithdrawal. For example, a therapeutic agent may be delivered into thebody lumen 90 via the first lumen 26 and outlet 27 of the outer member20, e.g., to at least partially dissolve or separate thrombus or otherrelatively soft material before being dilated by the balloon 50. Inaddition or alternatively, the distal portion 48 may carry one or moreother treatment elements, e.g., an abrasive tip, a passive or activeatherectomy tool, and the like (not shown), in addition to or instead ofthe balloon 50. Exemplary tips and methods for using them are disclosedin application Ser. No. 12/966,925, filed Dec. 13, 2010, the entiredisclosure of which is expressly incorporated by reference herein.

Optionally, as shown in FIG. 16B, a stent 96 may be carried by theballoon 50 and may be expanded by inflating the balloon 50. For example,with the valve of the apparatus 10 open, dye 95 may be injected into thebody lumen 90 to facilitate imaging and positioning the apparatus 10.Once the stent 96 is positioned across the occlusion 94, the valve maybe closed, and the balloon 50 may be inflated to expand the stent 96 anddilate the occlusion 94 (not shown). Once the stent 96 is expanded, theballoon 50 may be collapsed and the apparatus 10 removed from the bodylumen 90 and patient's body.

Alternatively, the apparatus 10 may be used to introduce and/or deployother prostheses instead of or in addition to the stent 96. For example,a tubular stent-graft, one or more components of a prosthetic valve, andthe like (not shown) may be carried by the distal portion 48, e.g., overthe balloon 50. The prosthesis may be expanded or otherwise deployedwithin a body lumen, e.g., by inflating the balloon 50, as describedabove, with fluid being selectively introduced, as desired.

Turning to FIG. 16C, in another method, the apparatus 10″ may be used asa drug delivery platform for treating the occlusion 94. For example, insome applications, it may be desirable to deliver an anti-restenosisdrug without a stent. As shown, the apparatus 10″ includes a carrier 98″provided over the balloon 50″ that may be delivered into the body lumen90 and/or through the occlusion 94″. For example, similar to the methodsdescribed above, the apparatus 10″ may be advanced into the body lumen90 with the balloon 50″ and the carrier 98″ thereon in a collapsedcondition, e.g., over the guidewire 99.

With the balloon 50″ positioned within the occlusion 94 and the valveopen, contrast, dye, or other fluid 95 may be delivered from the outlet27″ into the body lumen 90 to facilitate locating and/or measuring thesize of the occlusion 94 and/or body lumen 90, e.g., using fluoroscopy.Once the apparatus 10″ is positioned with the balloon 50″ across theocclusion 94, the valve may be closed and the balloon 50″ inflatedwithin the body lumen 90 to dilate the occlusion 94 and deliver thecarrier 98″. Once the carrier 98″ is delivered, the balloon 50″ may becollapsed and the apparatus 10″ removed from the body lumen 90 andpatient's body. One or more therapeutic agents may be positioned withinor otherwise carried by the carrier 98″ and, therefore, may remainwithin the dilated occlusion 94 to treat the body lumen 90.

Alternatively, the agent(s) may be delivered directly from the wall ofthe balloon 50″. For example, the agent(s) may be infused through thewall of the balloon 50″, e.g., by providing a porous layer on theballoon 50″ into which the agent(s) may be embedded or otherwise placed.In another alternative, the agent delivered into the body lumen 90 maybe provided from multiple components that may react or interact in situonce delivered together within the body lumen 90. For example, a firstcomponent (or one or more additional components less than all componentsof the agent) may be carried on the wall of the balloon 50″, e.g., in aporous layer or on a carrier 98″ disposed around the balloon 50″, asdescribed above. The second component (or multiple remaining componentsneeded for the agent) may be delivered via the outlet 27″ on theapparatus 10″. For example, after one or more components are deliveredby closing the valve and inflating the balloon 50″ within the occlusion94, the valve may be opened and a fluid carrying the one or moreremaining components may be delivered into the body lumen 90. Thecomponents may then combine to form an active drug or agent that maytreat the material of the occlusion 94 and/or otherwise treat the bodylumen 90.

In another alternative, a balloon (not shown) may be provided on thedistal end 24 of the outer member 20 or on the distal portion 48 of theinner member 30 distal to the balloon 50, if desired, similar toembodiments in the applications incorporated by reference herein. Such aballoon may be a non-compliant, high pressure balloon, e.g., fordilating the body lumen, or an elastic, compliant balloon forsubstantially sealing the body lumen to isolate one or more regions ofthe body lumen before infusion of fluid therein. In such alternatives,the outer and/or inner members 20, 30 may include one or more additionallumens, e.g., as shown in FIGS. 14A-14C, providing inflation lumens forsuch additional balloons.

Turning to FIGS. 7A-7C, another embodiment of an apparatus 210 is shownthat includes a tubular outer member 220, an elongate inner member 230,and a distal portion 248 carrying a treatment element, e.g., a stent orother prosthesis 296 covered by a cover or other constraint 298.Generally, the apparatus 210 may be operable in multiple modes, e.g.,first and second modes, by directing the inner member 230 between afirst or distal position and a second or proximal position for openingand closing a valve adjacent the distal portion 248, similar to otherembodiments herein. In addition, the apparatus 210 may be operable fordeploying the prosthesis carried on the distal portion 248, as describedfurther below.

The outer member 220 includes a proximal end 222 coupled to a handle260, a distal end 224 sized for introduction into a body lumen, and afirst lumen 226 extending between the proximal end 222 and an outlet 227in the distal end 224. The inner member 230 also includes a proximal end232, a distal end 234, and, optionally, may include a second lumen 236extending between the proximal end 232 and a distal tip 235. Inaddition, the inner member 230 may include an actuator member (notshown), e.g., slidably disposed within an actuator lumen (also notshown), coupled with the constraint 298 for selectively actuating theconstraint 298, e.g., advancing the constraint distally or otherwise todeploy the prosthesis 296, as described further below.

The inner member 230 may have a length relative to the outer member 220such that the inner member proximal end 230 is coupled to an actuator264 on the handle 260, and the inner member distal end 234 extendsdistally beyond the outlet 227 of the outer member 220, e.g., to definethe distal portion 248. The actuator 260 may be coupled to the proximalend 232 of the inner member 230 for directing the inner member 230axially relative to the outer member 220, e.g., to open or close theoutlet 227 and/or to direct the apparatus 210 between the differentmodes, similar to other embodiments herein.

Unlike the previous embodiments, the distal portion 248 includes theprosthesis 296 and constraint 298 adjacent a tapered proximal portion238, extending at least partially between the proximal portion 238 andthe distal tip 235. The tapered portion 238 may taper outwardly anddistally from the inner member 230 to define an outer diameter similarto or larger than the outlet 227 of the outer member 220, e.g., toprovide a sealing member for selectively sealing the outlet 227, similarto other embodiments herein. The tapered portion 238 may be formed frommaterial similar to the rest of the distal portion 248, or the taperedportion 238 may be formed from flexible and/or resilient material toenhance the seal with the outlet 227.

The inner member 230 may be movable between a first or distal position,shown in FIG. 7B, where the outlet 227 is spaced apart from the proximalportion 238, and a second or proximal position, shown in FIG. 7A, wherethe tapered portion 238 engages the outlet 227 to substantially seal theoutlet 227. For example, the actuator 262 may be directed between distaland proximal positions on the handle 260 to open and close the outlet227, as shown, e.g., to allow fluid to be delivered from the first lumen226 through the outlet 227 into a body lumen or other region adjacentthe distal portion 248.

The distal portion 248 may have an outer diameter similar to the maximumdiameter of the tapered portion 238, e.g., a substantially uniformdiameter between the tapered portion 238 and the distal tip 235.Alternatively, the distal portion 248 may step down from the taperedportion 238, e.g., to accommodate receiving the prosthesis 296 thereon.

As shown, the constraint 298 may be movable from a first positionoverlying the stent 296 and a second position for exposing the stent296. As best seen in FIG. 7C, an actuator 266 on the handle 260 may beadvanced distally to direct an actuator member (not shown) in the innermember 330 and consequently the constraint 298 distally to expose thestent 296. In the embodiment shown, the stent 296 may be self-expanding,i.e., biased to expand to a diameter larger than a body lumen withinwhich the stent 296 is intended to be deployed. Thus, as the constraint298 is advanced, the stent 296 may resiliently expand as it is exposeduntil the constraint 298 is advanced sufficiently to expose the entirestent 296. Alternatively, other constraints may be provided instead ofthe sleeve 298 shown, e.g., one or filaments or elements (not shown)that may surround the stent 296 and/or secure the stent 296 on thedistal portion 248 in a constrained state, yet may be withdrawn torelease the stent 296 from the constrained state and allow the stent 296to resiliently expand to a deployed state.

In addition or alternatively, a balloon or other expandable member (notshown) may be provided on the distal portion 248, e.g., underlying thestent 296. In this embodiment, the balloon may be inflated, e.g., bydelivering fluid through the first lumen 266 with the inner member 230in the second position such that the fluid passes through the outlet 227and one or more passages (not shown) in the tapered portion 238 into aninterior of the balloon. For example, the balloon may be inflated toplastically or otherwise further expand the stent 296 after deploymentand/or dilate the body lumen within which the stent 296 is deployed.

In a further alternative, the stent 296 may be plastically expandable,e.g., similar to the embodiments described elsewhere herein. In thisalternative, the constraint 298 may still be provided, if it is desiredto protect the stent 296 (or other prosthesis) and/or provide atransition over the distal portion 248. Alternatively, the constraint298 may be omitted and the stent 296 may be maintained on the distalportion 248, e.g., by compressing the stent 296 or by the stent 296having a substantially relaxed state corresponding to the constrainedstate. In this alternative, a balloon or other expandable member (notshown) may be provided on the distal portion 248 to expand the stent296, similar to other embodiments herein.

Turning to FIGS. 8A and 8B, another embodiment of an apparatus 310 isshown that includes a tubular outer member 320, an elongate inner member330, and a distal portion 348, which may carry a treatment element,e.g., a balloon, stent or other prosthesis, and the like (not shown).The outer member 320 includes a proximal end coupled to a handle (notshown), a distal end 324 sized for introduction into a body lumen, and afirst lumen 326 extending between the proximal end and an outlet 827 inthe distal end 324.

The inner member 330 also includes a proximal end (not shown), a distalend 334, and, optionally, may include a second lumen 336 extendingbetween the proximal end and a distal tip 335. The inner member 330 maybe coupled to an actuator (not shown) on the handle, e.g., for directingthe inner member 330 between a first or distal position, shown in FIG.8A, and a second or proximal position, shown in FIG. 8B, for opening andclosing a valve adjacent the distal portion 348.

For example, as shown, the distal portion 348 may extend from a taperedproximal portion 338 to the distal tip 335. Similar to the apparatus 210shown in FIGS. 7A-7C, the tapered portion 338 may taper outwardly anddistally from the inner member 330 to define an outer diameter similarto or larger than the outlet 327 of the outer member 320, e.g., toprovide a sealing member for selectively sealing the outlet 327, similarto other embodiments herein. The tapered portion 338 may be formed frommaterial similar to the rest of the distal portion 348, or the taperedportion 338 may be formed from flexible and/or resilient material toenhance the seal with the outlet 327. Alternatively, a separate sealingmember (not shown) may be formed on or attached to the distal end 334 ofthe inner member 330, e.g., similar to the sealing members 38, 38′described previously. In this alternative, the distal portion 348 mayhave a diameter similar to other portions of the inner member 330.

As shown, the distal portion 348 may include one or more passages 339extending at least partially along a length thereof, e.g., from one ormore proximal ports 339 a in the tapered portion 338 to one or morerespective distal ports 339 b in the distal portion, e.g., adjacent thedistal tip 335. Optionally, the distal portion 348 may include a balloonor other expandable member (not shown), a stent or other prosthesis,and/or other treatment elements, similar to previous embodiments. Forexample, a balloon may be attached to the distal end 334 of the innermember 330 such that an interior of the balloon communicates with aninflation lumen (not shown) in the inner member 330, which may be thelumen 336 or a separate lumen, e.g., similar to the configuration shownin FIG. 14C.

The inner member 330 may be movable between a first or distal position,shown in FIG. 8A, where the outlet 327 is spaced apart from the proximalportion 338, and a second or proximal position, shown in FIG. 8B, wherethe tapered portion 338 engages the outlet 327 to substantially seal theoutlet 327. For example, the actuator may be directed between distal andproximal positions on the handle to open and close the outlet 327. Withthe outlet 327 open and the inner member 330 in the first position, asshown in FIG. 8A, fluid delivered through the first lumen 326 may exitthe outlet 327 into a body lumen or other region adjacent, e.g.,proximal to, the distal portion 348, as represented by arrows 95. Withthe outlet 327 closed and the inner member 330 in the second position,as shown in FIG. 8B, fluid delivered through the first lumen 326 mayenter the proximal port(s) 339 a of the passage(s) 339 and exit thedistal port(s) 339 b, e.g., distally beyond the distal portion 348, asrepresented by arrows 95.

Thus, the inner member 348 may be actuated to selectively deliver fluidon either side of the distal portion 348. During use, the apparatus 310may be introduced into a body lumen to perform one or more medicalprocedures, similar to the other embodiments herein. For example, thedistal portion 348 may be positioned at a target treatment site, and atreatment element (not shown) on the distal portion 348 may be used totreat the target site. During such treatment, fluid may be deliveredproximal or distal to the treatment element, e.g., to monitor use of thetreatment element, similar to other embodiments herein.

Turning to FIGS. 9-10B, another embodiment of an apparatus 410 is shownfor treating a body lumen that includes an outer tubular member 420, aninner member 430, and an expandable balloon 450 carried by the innerand/or outer members 420, 430. Similar to the previous embodiments, theapparatus 410 may be operable in multiple modes, for example, a firstmode for delivering fluid into a body lumen (FIG. 10B), and a secondmode for expanding the balloon 450 (FIG. 10B), e.g., to remove material,dilate, or otherwise treat a body lumen, deliver a prosthesis, and thelike, similar to other embodiments herein.

As best seen in FIG. 9, the outer member 420 includes a proximal end422, a distal end 424 sized for introduction into a body lumen, and afirst lumen 426 extending therebetween. The inner member 430 alsoincludes a proximal end (not shown), a distal end 434, and, optionally,may include a second lumen 436 extending between the proximal and distalends 434, which may be sized to slidably receive a guide wire or otherinstrument (not shown) therethrough.

The balloon 450 includes a proximal end 452 coupled to the outer memberdistal end 424, a distal end 454 including an outlet 458, and aninterior 456 communicating with the first lumen 426 and the outlet 458.The distal end 454 of the balloon 450 may be integrally formed with themain wall of the balloon 450 (defining the interior 456), and,optionally, the proximal end 452 of the balloon 450. The balloon 450 maybe formed from elastic material, e.g., to provide a compliant orsemi-compliant balloon, or from substantially inelastic material, e.g.,to provide a non-compliant balloon, similar to other embodiments hereinand in the applications incorporated by reference herein.

As best seen in FIGS. 10A and 10B, a distal tip 435 may be integrallyformed with, attached to, or otherwise provided on the distal end 454 ofthe balloon 450, e.g., surrounding or otherwise defining the outlet 458and/or reinforcing the distal end 454. For example, as shown, the distaltip 435 may include a tapered outer shape, e.g., to provide asubstantially atraumatic tip for the balloon 450. In addition, thedistal tip 435 includes a stepped-down inner surface, e.g., defining arelatively small diameter distal region 435 a and a relatively largediameter proximal region 435 b. Optionally, a valve seal liner 437 maybe provided within the outlet 458, e.g., in the recess defined by thestepped-down regions 435 a, 435 b, to further support the outlet 458and/or distal tip 435, if desired. The valve seal liner 437 may be aseparate sleeve attached to the distal tip 435, e.g., by an interferencefit, bonding with adhesive, sonic welding, fusing, and the like. Forexample, the liner sleeve may be formed from a tube or other materialhaving greater radial and/or longitudinal rigidity than the distal tip454 of the balloon 450. Alternatively, the valve seal liner 437 may beintegrally formed with the distal tip 435 and/or distal end 454 of theballoon 450, e.g., with properties of the material modified to enhancesupport of the distal end 454 and/or outlet 458.

A sealing or valve member 438 may be carried on the inner member distalend 434, e.g., such that the sealing member 438 is movable relative tothe balloon 450 as the inner member 430 is moved, e.g., for selectivelyopening and closing the outlet 458 to provide a valve. Unlike theprevious embodiments, the sealing member 438 is disposed within theinterior 456 of the balloon 450 such that the sealing member 438 may bespaced apart from the outlet 458 in the proximal or first position toopen the outlet 458, and may be seated within the distal end 454 and/ordistal tip 435 in the distal or second position to seal the outlet 458.

For example, the sealing member 438 may include a main valve body 438 ahaving a size, e.g., outer diameter, such that the valve body 438 a maybe slidably received within or through the outlet 458 in the distalposition. Optionally, the sealing member 438 may have a tapered shape,e.g., to guide or otherwise facilitate seating the sealing member 438within the outlet 458 and/or to provide an atraumatic tip when thesealing member 438 is seated in the outlet 458. The sealing member 438may be formed from flexible material, e.g., which may enhance engagementwith the distal end 454 of the balloon 450 and/or the distal tip 435.Optionally, the sealing member 438 may include a substantiallyatraumatic tip, e.g., a rounded, softened, beveled, or “J” or othercurved tip, (not shown), that may extend beyond the distal tip 435,similar to embodiments in the applications incorporated by referenceherein.

One or more valve seals, e.g., annular valve seal 438 b may beintegrally formed on or attached to the valve body 438 a, similar toprevious embodiments, e.g., to enhance a seal between the sealing member438 and the distal end 454 of the balloon 450 and/or the distal tip 435.In addition or alternatively, a stop 478 may be provided on the sealingmember 438 for limiting distal movement of the inner member 430 relativeto the distal end 454 of the balloon 450. As best seen in FIGS. 10A and10B, the stop 478 may be a band attached around the sealing member 438proximal to the valve seal 438 b.

For example, as shown in FIG. 10A, the inner member 430 may be directedproximally, e.g., until the sealing member 438 is withdrawn entirelyinto the interior 456 of the balloon 450, thereby opening the outlet458. Thus, fluid delivered into the first lumen 426 passes through theinterior 456 and distal end 454 of the balloon 450 and through thedistal tip 435 and outlet 458 into the body lumen beyond the apparatus410. Alternatively, the inner member 430 may be withdrawn to partiallywithdraw the sealing member 438 from the outlet 458, e.g., as shown inFIG. 15A, to provide some resistance to flow through the outlet 458 suchthat the balloon 450 is partially inflated while fluid is delivered fromthe outlet 458.

Turning to FIG. 10B, the inner member 430 may be directed distally todirect the sealing member 438 into and/or through the distal end 454 ofthe balloon 450 and/or the distal tip 435 to substantially seal theoutlet 458. The sealing member 438 and/or distal end 454, e.g., thevalve seal liner 437 and the valve seal 438 b, may be sufficientlyflexible to contact one another with a relatively high contact pressure,e.g., by deformation of one or both of the valve seal liner 437 and/orthe valve seal 438 b, to provide a substantially fluid-tight seal withminimal friction. Thus, in this position, fluid delivered into the firstlumen 426 of the outer member 420 may remain within the balloon interior456 to expand the balloon 450.

As shown, the stop 478 and valve seal liner 437 may have substantiallyflat and/or blunt end surfaces that contact one another, e.g., toprevent further advancement of the inner member 430. The stop 478 andvalve seal liner 437 may provide sufficient support to reduce the riskof the distal end 454 of the balloon 450 migrating distally as mayotherwise occur as pressurized fluid is delivered into the interior 456to expand the balloon 450. Optionally, the inner member 430 may beadvanced to press the stop 478 against the distal end 454 and/or distaltip 435 and push the distal end 454 of the balloon 450 away from theproximal end (not shown), thereby slightly stretching the balloon 450and/or enhancing the seal. This configuration may also minimize orotherwise reduce the profile of the balloon 450, e.g., to facilitateintroduction into a patient's body. Alternatively, distal advancement ofthe inner member 430 may be limited, e.g., by an actuator on theproximal end (not shown) of the apparatus 410. Optionally, the valveseal liner 437, distal end 454, distal tip 435, and/or the sealingmember 438 may include a lubricious coating or material, such as PTFE,if desired to reduce friction between the components, similar toembodiments in the applications incorporated by reference herein.

With the inner member 430 advanced to close the outlet 458, the sealingmember 438 may be received substantially within the distal end 454 ofthe balloon 450 and/or the distal tip 435. Thus, the sealing member 438may be disposed substantially entirely beyond the expandable portion ofthe balloon 450, i.e., outside the interior 456. This configuration mayfacilitate folding, compressing, or otherwise minimizing a profile ofthe balloon 450 in its collapsed condition, which may facilitateintroduction of the apparatus 410 into a body lumen.

In an alternative embodiment, shown in FIG. 11, an apparatus 410′ may beprovided generally similar to the apparatus 410, e.g., including anouter member 420′, an inner member 430′ including a sealing member 438′,and a balloon 450′ including an outlet 458′. Unlike the previousembodiment, a tensioning element 457′ is coupled to the balloon 450′,e.g., a spring or support with opposing ends coupled to proximal anddistal ends 452′, 454′ of the balloon 450′. The tensioning element 457′may apply a substantially constant tension on the balloon 450′ pushingthe ends 452′, 454′ away from one another. For example, if friction isencountered when the inner member 430′ is directed proximally towithdraw the sealing member 438′ from the distal end 452′ to open theoutlet 458′, the tension may prevent the distal end 454′ of the balloon450′ from following the sealing member 438′ and buckling or otherwisecompressing the balloon 450′ axially rather than opening the outlet458′.

Turning to FIGS. 12A and 12B, another embodiment of an apparatus 410″ isshown for treating a body lumen that includes an outer tubular member(not shown), an inner member 430″ with a sealing member 438″, and anexpandable balloon 450″ carried by the outer member and inner member430″, generally similar to previous embodiments. Also similar toprevious embodiments, the apparatus 410″ may be operable in multiplemodes, e.g., a first mode for infusing fluid into a body lumen viaoutlet 458″ (FIG. 12A), and a second mode where the outlet 458″ issealed by the sealing member 438″ for expanding the balloon 450″ (FIG.12B).

The outer member includes a proximal end, a distal end sized forintroduction into a body lumen, and a first lumen extending between theproximal and distal ends (not shown), which may be constructed similarto previous embodiments. The inner member 430″ also includes a proximalend (not shown), a distal end 434″, and, optionally, a second lumen 436″extending therebetween. The inner member 430″ is slidably receivedwithin the first lumen of the outer member, e.g., such that an annularspace is defined between the outer and inner members 430″ for passingone or more fluids therethrough, also similar to previous embodiments.

The balloon 450″ includes a proximal end (not shown) coupled to theouter member distal end, a distal end 454″ defining the outlet 458″, andan interior 456″ communicating with the first lumen and the outlet 458″.The balloon 450″ may be formed from elastic material, e.g., to provide acompliant or semi-compliant balloon, or from substantially inelasticmaterial, e.g., to provide a non-compliant balloon, similar to otherembodiments herein. A distal tip 435″ may be integrally formed with,attached to, or otherwise provided on the distal end 454″ of the balloon450, e.g., surrounding or otherwise defining the outlet 458″ and/orreinforcing the distal end 454″. As shown, the distal tip 435″ mayinclude a tapered outer shape, e.g., to provide a substantiallyatraumatic tip for the balloon 450″ when the sealing member 328″ isfully seated in the outlet 458″.

In addition, the distal tip 435″ includes a stepped-down inner surface,e.g., defining a relatively small diameter distal region 435 a″ and arelatively large diameter proximal region 435 b″. Optionally, a valveseal liner (not shown) may be provided within the outlet 458″, e.g., inthe recess defined by the stepped-down regions 435 a″, 435 b″, similarto the previous embodiment.

A sealing or valve member 438″ may be carried on the inner member distalend 434″, e.g., within the interior 456″ of the balloon 450″, such thatthe sealing member 438″ is movable relative to the balloon 450″ as theinner member 430″ is moved, e.g., for selectively opening and closingthe outlet 458″ to provide a valve. Similar to previous embodiments, thesealing member 438″ may be spaced apart from the outlet 458″ in theproximal or first position to open the outlet 458″ (FIG. 12A) and may beseated within the distal tip 435″ in the distal or second position toseal the outlet 458″ (FIG. 12B).

As shown, the sealing member 438″ includes a main valve body 438 a″having a size, e.g., outer diameter, such that the valve body 438 a″ maybe slidably received within or through the outlet 458″, e.g., throughthe distal region 435 a″ of the distal tip 435″ in the distal position.Optionally, the sealing member 438″ may have a tapered shape, e.g., tofacilitate seating or other engagement by the sealing member 438″ withthe distal tip 435″ and/or to provide an atraumatic tip when the sealingmember 438″ is seated within the outlet 458″. The sealing member 438″may be formed from flexible material, e.g., which may enhance engagementwith the distal tip 435″ and/or distal end 454″ of the balloon 450″.

An annular valve seal 438 b″ may be integrally formed on or attached tothe valve body 438 a″, similar to previous embodiments, to enhance aseal between the sealing member 438″ and the distal tip 435″ and/ordistal end 454″ of the balloon 450″. In addition or alternatively, astop 478″ may be provided on the sealing member 438″ for limiting distalmovement of the inner member 430″ relative to the distal end 454″ of theballoon 450″.

The valve seal 438 b″ may be sufficiently flexible such that the valveseal 438 b″ is compressed slightly inwardly when received within thedistal end 454″ and/or outlet 458″, e.g., within the proximal region 435b″ of the distal tip 435″, to provide a substantially fluid-tight sealwithout creating substantial friction between the valve seal 438 b″ andthe distal end 454″. Alternatively, as shown in FIGS. 13A and 13B, asealing member 438″′ may be provided that includes a valve seal 438 b″′that has a relaxed outer diameter that is slightly smaller than theproximal region 435 b″′ of the distal end 454″′. Thus, the valve seal438 b″′ and sealing member 438″′ may be freely seated and/or withdrawnfrom the outlet 458″′ and/or distal end 454″′ with minimal or nointerference and/or friction, as shown in FIG. 13A.

However, in this alternative, the valve seal 438 b″′ may be formed fromrelatively soft, flexible material such that, as shown in FIG. 13B, whenthe inner member 430″′ is pushed distally with sufficient force, thevalve seal 438 b″ may compress axially and consequently expand radially,thereby engaging the proximal region 435 b″′ of the distal tip 435″′.This interference fit may then provide a substantially fluid-tight sealof the outlet 458″′. In addition, as the balloon 450″′ is inflated, thepressurization within the interior 456″′ may apply a distal force on thesealing member 438″′ to further compress the sealing member 438″′ andexpand the valve seal 438 b″′. Once the internal pressure within theballoon 450″′ and/or distal force on the inner member 430″′ is removed,the valve seal 438 b″′ may resiliently contract radially, therebydisengaging the proximal region 435 b″′ and reducing any interference orfriction that may otherwise resist withdrawal of the sealing member438″′ from the outlet 458″.

Returning to FIGS. 12A and 12B, as shown, a tensioning element 457″ maybe provided for applying tension on the balloon 450″ (or otherembodiments herein), e.g., to push the distal end 454″ distally. Asshown, the tensioning element 457″ may be a compression spring with afirst end 457 a″ coupled to the stop 478″ on the sealing member 438″ anda second end 457 a″ coupled to the distal end 454″, e.g., the recessbetween the stepped-down regions 435 a″, 435 b″. The tensioning element457″ may be configured for applying a predetermined, e.g., substantiallyconstant, tension between the inner member 330″ and the distal end 454″of the balloon 450″, e.g., to apply tension between the proximal anddistal ends 452″, 454″ of the balloon 450″ during use of the apparatus410″.

For example, as shown in FIG. 12A, the inner member 430″ may be directedto a proximal or first position, e.g., where the sealing member 438″ iswithdrawn entirely into the interior 456″ of the balloon 450″, therebyopening the outlet 458″. Thus, fluid delivered into the first lumen 426″passes through the interior 456″ and distal end 454″ of the balloon 450″and through the distal tip 435″ and outlet 458″ into the body lumenbeyond the apparatus 410″ without substantial expansion of the balloon450″ (or partial expansion of the balloon 450″, similar to the apparatus410 shown in FIG. 15A and described further below). In the proximalposition, the tensioning element 457″ may be under slight compression orin a substantially relaxed state, e.g., such that the tensioning element457″ is not stretched or otherwise plastically deformed.

Turning to FIG. 12B, the inner member 430″ may be directed to a distalor second position, where the sealing member 438″ is advanced intoand/or through the distal tip 435″ and/or distal end 454″ of the balloon450″ to substantially seal the outlet 458″. As the inner member 430″ isadvanced, the tensioning element 457″ may be compressed, thereby biasingthe distal tip 435″ and/or distal end 454″ to move distally away fromthe sealing member 438″. In this position, fluid delivered into thefirst lumen 426″ of the outer member 420″ may remain within the ballooninterior 456″ to expand the balloon 450″, similar to previousembodiments.

Subsequently, if the inner member 430″ and sealing member 438″ are againdirected proximally to open the outlet 458″, the tensioning member 457″may ensure that the distal end 454″ and distal tip 435″ do not moveproximally with the sealing member 438″. For example, as explainedabove, if friction is encountered between the sealing member 438″ anddistal tip 435″ when the inner member 430″ is directed proximally toopen the outlet 458″, the force of the tensioning element 457″ mayprevent the distal end 454″ of the balloon 450″ from following thesealing member 438″ and potentially buckling or compressing the balloon450″ rather than opening the outlet 458″.

During use, any of the apparatus 410-410″′ may be used to perform one ormore procedures within a body, similar to the other apparatus andmethods described elsewhere herein and in the applications incorporatedby reference herein. For example, with reference to the apparatus 410 ofFIGS. 9-10B, with the sealing member 438 sealing the outlet 458 and theballoon 450 in a contracted condition, the apparatus 410 may beintroduced into a patient's body, e.g., into a body lumen, such as ablood vessel (not shown). When desired, the sealing member 438 may bedirected to the proximal position to withdraw the sealing member 438from the distal tip 435 and/or distal end 454, and deliver fluid, suchas contrast, dyes, therapeutic agents, and the like, via the outlet 458into the body lumen, similar to other embodiments herein. Once theballoon 450 is positioned at a desired location, the sealing member 438may be advanced to the distal position to seal the outlet 458, and theballoon 450 may be expanded within the body lumen, e.g., to removematerial, dilate the body lumen, expand a prosthesis (not shown) carriedon the balloon 450, deliver agents (also not shown) carried by theballoon 450, and the like, similar to other embodiments herein.

Optionally, as shown in FIG. 15A, during use, the sealing member 438 maybe directed to an intermediate position such that the outlet 458 is notfully sealed. Thus, when fluid is introduced through the first lumen 426of the outer member 420 into the interior 456 of the balloon 450, theballoon 450 may be partially inflated, while fluid also exits the outlet458. The relative amount of expansion and fluid delivery may be manuallyadjusted, if desired, e.g., based upon the anatomy and/or intendedprocedure. For example, the handle may include an indicator (not shown)to identify one or more intermediate positions. In addition, the usermay be able to identify an intermediate position based on resistance tofluid being injected, e.g., with increased resistance indicating thatthe balloon 450 is being inflated.

In an exemplary procedure, it may be desirable to substantially fill abody lumen with radiopaque contrast to facilitate imaging withoutnatural flow within the body lumen washing the contrast away too quicklyto obtain a clear image. At least partially inflating the balloon 450may reduce flow through the body lumen to allow contrast delivered fromthe outlet 458 to dwell within the body lumen to enhance such imaging.For example, once sufficient fluid is introduced into the body lumen andballoon 450, the sealing member 438 may be advanced to seal the outlet458 and maintain the balloon 450 in the partially or fully expandedcondition for a desired amount of time. After sufficient time haspassed, vacuum may be applied to the first lumen 426 to evacuate fluidfrom the balloon 450 to collapse the balloon 450 and restore normalflow. Alternatively, the sealing member 438 may be withdrawn to open theoutlet 458 and allow the balloon 450 to deflate and/or vacuum may beapplied to evacuate fluid from the body lumen as well as the balloon450.

In another exemplary procedure, one or more therapeutic agents, such asthrombus lysing agents or vasodilators, may be delivered into a bodylumen via the outlet 458. Causing the balloon 450 to at least partiallyexpand may allow greater residence time of the agent(s) in a targettreatment site. As a result, there may be improved effectiveness of theagent(s) and/or smaller volumes may be delivered since natural flowthrough the body lumen may be temporarily slowed or stopped by theballoon 450.

Turning to FIG. 17, still another embodiment of an apparatus 510 isshown for treating a body lumen similar to other embodiments herein. Asshown, the apparatus 510 includes an outer tubular member 520, an innermember 530, an expandable balloon 550, and a handle 560, which may beconstructed similar to previous embodiments and the embodiments in theapplications incorporated by reference herein.

The outer member 520 includes a proximal end (not shown), a distal end524 sized for introduction into a body lumen, and a first lumen 526extending along a central longitudinal axis 527 therebetween. The innermember 530 also includes a proximal end (not shown), a distal end 534,and, optionally, a second lumen 536, e.g., sized to slidably receive aguidewire or other instrument (not shown) therethrough. The inner member530 may be slidably received within the first lumen 526 of the outermember 520, e.g., such that an annular space is defined between theouter and inner members 520, 530 for passing one or more fluidstherethrough, also similar to previous embodiments. One or more sealingmembers, e.g., a nosecone 538, may be provided on the distal end 534 ofthe inner member 530 to provide a valve, also similar to previousembodiments.

Unlike previous embodiments, the balloon 550 includes proximal anddistal ends 552, 554 that are both attached or otherwise coupled to theouter member 520. The outer member 520 includes one or more openings 529in the distal end 524 such that an interior 556 communicates with thefirst lumen 526 via the opening(s) 529. The distal end 534 of the innermember 530 may extend through the distal end 524 of the outer member520, e.g., beyond an outlet 558 in the outer member 520 such that theoutlet 558 defines an annular passage between the outer and innermembers 520, 530. Alternatively, the distal end of the balloon may beattached to the inner member or the distal end of the balloon mayinclude an outlet end that surrounds the inner member, e.g., similar toembodiments disclosed elsewhere herein and in the applicationsincorporated by reference herein.

With continued reference to FIG. 17, the handle 560 may be attached toor otherwise provided on the proximal end of the outer member 520, e.g.,for manipulating the outer member 520 and/or the entire apparatus 510.Similar to previous embodiments and embodiments in the applicationsincorporated by reference herein, the handle 560 may include an actuator(not shown) for operating the apparatus 510 in multiple modes, e.g., afirst mode for dilating an obstruction within a body lumen, and a secondmode for infusing fluid into a body lumen. For example, the actuator maybe movable to direct the inner member 530 relative to the outer member520 between a first or proximal position where the nosecone 538 may bepartially received in or otherwise engage the distal end 524 of theouter member 520 to substantially seal the outlet 558 and a second ordistal position where the nosecone 538 is spaced away from the outermember 520 to open the outlet 558, similar to previous embodiments.

With the nosecone 538 sealing the outlet 558, any fluid introduced intothe first lumen 526 enters the interior 556 of the balloon 550, therebyexpanding the balloon 550. Unlike previous embodiments, because both theproximal and distal ends 552, 554 of the balloon 550 are attached to theouter member 520, the length of the balloon 550 may remain substantiallyconstant during expansion and/or collapse. With the nosecone 538directed away from the outer member 520 to open the outlet 558, theballoon 550 may remain collapsed and any fluid introduced through thefirst lumen 526 may exit the outlet 558 into a body lumen within whichthe apparatus 510 is introduced.

As shown, the inner member 530 may be integrally incorporated into theapparatus 510, similar to previous embodiments. Alternatively, the innermember 530 may be decoupled or independent from the other components ofthe apparatus 510. For example, in one embodiment, the inner member 530may be introduceable into a patient's body independently from the outermember 520, e.g., over a guidewire or instead of a guidewire. Once thedistal end 534 is positioned at a desired location within the patient'sbody, the rest of the apparatus 510, i.e., the outer member 520 with theballoon 550 collapsed may be advanced over the inner member 530 to thedesired location.

For example, the proximal end of the inner member 530 extending from thepatient's body may be backloaded through the outlet 558, and the outermember 520 advanced until the proximal end of the inner member 530 isreceived in or extends from the handle 560. The relative length of theouter and inner members 520, 530 may be such that the outlet 558 isdisposed adjacent the nosecone 538 when the proximal end of the innermember 530 is received in or extends from the handle 560.

If desired, the handle 560 may include a coupler (not shown) that may beactivated to engage the inner member 530 to a push button, thumbcontrol, or other actuator (not shown) on the handle 560 once the outermember 520 is advanced sufficiently over the inner member 530. Thus,subsequently, the actuator may be activated to direct the inner member530 and nosecone 538 axially relative to the outer member 520 to seal oropen the outlet 558. It will be appreciated that other embodimentsdescribed elsewhere herein may be decoupled in this manner, i.e.,provided with the inner member independent from the outer member and/orother components of the apparatus.

Optionally, an independent inner member 530 may include one or moremarkers or other visual indicators (not shown) that may provideconfirmation to a user that the outer member 520 has been advancedsufficiently to place the outlet 558 adjacent the nosecone 538. Forexample, a marker may be provided on the proximal end of the innermember 530 that may be visible when the proximal end of the inner member530 extends from the handle 560, thereby providing a visual indicationthat the nosecone 538 is sealing or adjacent the outlet 558. In additionor alternatively, the outer member 520 may be advanced until the distalend 524 contacts or engages the nosecone 538, which may provide tactilefeedback that the nosecone 538 may be used to seal or open the outlet558.

With the outer member 520 advanced over the inner member 530, the outlet558 may be opened and fluid delivered into the desired location, e.g.,contrast to facilitate imaging the desired location, or one or morediagnostic and/or therapeutic agents. If desired to expand the balloon550, the nosecone 538 may be directed proximally to seal the outlet 558,and fluid delivered to inflate the balloon 550, e.g., to dilate astenosis or other lesion at the desired location, similar to methodsdescribed elsewhere herein. After treating the desired location, theapparatus 510 may be directed to another location or removed from thepatient's body. For example, the outer and inner members 520, 530 may beremoved together or the outer member 520 may be removed first (e.g.,after decoupling the outer member 520 from the inner member 530 ifcoupled together after advancing the outer member 520 over the innermember 530).

In alternative embodiments, one or more treatment elements may beprovided in addition to or instead of the balloon 550. For example, asshown in FIG. 18A, an apparatus 510 a may be provided that is generallysimilar to apparatus 510, except that a prosthesis 596 a is provided onthe distal end 524 a. In an exemplary embodiment, the prosthesis 596 amay be a stent that may be crimped or otherwise loaded over the balloon550 a. Once the distal end 524 a of the apparatus 510 a is positionedwithin a target treatment site, e.g., after opening the outlet 558 a todeliver contrast and facilitate positioning the stent 596 a, the outlet558 a may be sealed with the nosecone 538 a, and the balloon 550 ainflated to expand the stent 596 a within the target treatment site,e.g., to dilate and support an obstructed region within a blood vessel.Alternatively, other prostheses may be loaded on the apparatus 510 a,such as a stent-graft, a prosthetic valve, and the like, similar toother embodiments herein.

Turning to FIG. 18B, another embodiment of an apparatus 510 b is shownthat includes a plurality of treatment elements, namely a plurality ofelectrodes or other conductive elements 596 b on the balloon 550 b. Theelements 596 b may be attached to or embedded in the balloon wall 550 bin a desired pattern, e.g., a plurality of longitudinal elements spacedapart from one another about a circumference of the balloon 550 b, asshown. The elements 596 b may be coupled to an energy source, e.g., aradiofrequency generator coupled to a handle (not shown) on the proximalend of the apparatus 510 b. For example, a plurality of wires or otherconductors (not shown) may extend through the outer member 520 b fromthe elements 596 b to a connector on the handle (not shown) to which thegenerator may be connected.

During use, once the distal end 524 b of the apparatus 510 b has beenpositioned within a target treatment site, e.g., within a blood vessel,heart chamber, and the like (not shown), the balloon 550 b may beinflated to expand the elements 596 b, e.g., to press them against thewall of the body lumen. The generator may then be activated to deliverenergy into the wall via the elements 596 b, to ablate, heat, orotherwise treat tissue surrounding the body lumen. Similar to previousembodiments, the outlet 558 b may be selectively opened and closedduring the procedure, e.g., before or after delivering the energy, tofacilitate imaging, or otherwise monitor or enhance treatment.

Turning to 18C, yet another embodiment of an apparatus 510 c is shownthat includes one or more cryogenic treatment elements 596 c carried bythe balloon 550 c and/or the distal end 524 c of the apparatus 510 c. Inan exemplary embodiment, the cryogenic element(s) may include a coolingapparatus within the balloon 550 c powered by compressed gas havingthermodynamic properties that cause cooling upon expansion of the gaswithin the interior of the balloon 550 c.

During use, once the distal end 524 c of the apparatus 510 c has beenpositioned within a target treatment site, e.g., within a blood vessel,heart chamber, and the like (not shown), the balloon 550 c may beinflated, e.g., to press the balloon 550 c against the wall of the bodylumen. Cooling gas may then be released within the interior of theballoon 550 c to cool surrounding tissues to freeze, modify, orotherwise treat tissue surrounding the body lumen, e.g., to reduce therisk of restenosis within a blood vessel. Similar to previousembodiments, the outlet 558 c may be selectively opened and closedduring the procedure, e.g., before or after delivering the cooling gas,to facilitate imaging, or otherwise monitor or enhance treatment.

Turning to FIGS. 19A and 19B, another embodiment of an apparatus 610 isshown that includes an outer tubular member 620, an inner member 630,and an expandable balloon 650, which may be constructed similar toprevious embodiments and the embodiments in the applicationsincorporated by reference herein. For example, the outer member 620 mayinclude a proximal end (not shown), a distal end 624 sized forintroduction into a body lumen, and a first lumen 626 extendingtherebetween.

The inner member 630 also includes a proximal end (not shown), a distalend 634, and a second lumen 636 extending therebetween. Unlike theprevious embodiments, the second lumen 636 may be sized for receivingone or more instruments therethrough, e.g., one or more catheters,sheaths, or other devices (not shown), which may be substantially largerthan a guidewire. For example, the second lumen 636 may have a diameterbetween about one and four millimeters (1-4 mm). Thus, the apparatus 610may provide a guide catheter or guide sheath that may be introduced intoa body lumen and through which one or more other devices may beintroduced to perform a procedure. Optionally, a dilator (not shown) maybe provided within the second lumen 636, e.g., to support the apparatus610 and/or to provide a transition or atraumatic tip for the apparatus610.

Similar to previous embodiments, the inner member 630 may be slidablyreceived within the first lumen 626 of the outer member 620, e.g., suchthat an annular space is defined between the outer and inner members620, 630 for passing one or more fluids therethrough. One or moresealing members, e.g., a nosecone 638, may be provided on the distal end634 of the inner member 630 to provide a valve, also similar to previousembodiments.

The balloon 650 includes proximal and distal ends 652, 654 that are bothattached or otherwise coupled to the outer member 620, and the outermember 620 may include one or more openings (not shown) in the distalend 624 such that an interior of the balloon 650 communicates with thefirst lumen 626 via the opening(s). The distal end 634 of the innermember 630 may extend through the distal end 624 of the outer member620, e.g., beyond an outlet 658 in the outer member 620 such that theoutlet 658 defines an annular passage between the outer and innermembers 620, 630. Alternatively, the distal end 654 of the balloon 650may be attached to the inner member 630 or the distal end 654 of theballoon 650 may include an outlet end that surrounds the inner member,e.g., similar to embodiments disclosed elsewhere herein and in theapplications incorporated by reference herein.

With the nosecone 638 sealing the outlet 658, any fluid introduced intothe first lumen 626 enters the interior of the balloon 650, therebyexpanding the balloon 650. With the nosecone 638 directed away from theouter member 620 to open the outlet 658, the balloon 650 may remaincollapsed and any fluid introduced through the first lumen 626 may exitthe outlet 658 into a body lumen within which the apparatus 610 isintroduced. Thus, the apparatus 610 may provide a guide or access sheaththat includes a valve adjacent the balloon 650, which may be selectivelyopened and closed to deliver fluid when the second lumen 636 is used forother purposes.

Turning to FIGS. 20A and 20B, still another embodiment of an apparatus710 is shown that includes a catheter or other elongate member 720including proximal and distal ends 722, 724 and a balloon 750 carried onthe distal end 724. Optionally, the apparatus 710 may include an innermember and/or valve (not shown), similar to previous embodiments andembodiments in the applications incorporated by reference herein.

In addition, the apparatus 710 includes a handle 750 coupled to orotherwise on the proximal end 722 that includes an integrated inflationdevice. Previous embodiments generally include a handle with a port towhich an external inflation device, such as a syringe and the like (notshown) may be coupled. Thus, unlike the previous embodiments, theapparatus 710 includes an inflation device incorporated directly intothe handle 750.

Generally, the inflation device includes a barrel or housing 752 and apiston 754 slidably received in the barrel 752 such that a fluid-tightseal is provided between the piston 754 and barrel 752. The handle 750may include a fixed gripping surface 756 coupled to the barrel 752 and amovable gripping surface 758 coupled to the piston 754. A pressure gauge766 may be attached to the barrel 752 to provide an indicator of thepressure of fluid within the barrel 752. A filling port 768 is attachedto or extends from the barrel 752, e.g., including a valve that may beselectively opened and closed, to allow fluids (e.g., liquids or gases)to be delivered into or removed from the barrel 752. For example, whenthe balloon 750 is to be inflated, the valve may be closed to provide afixed volume of fluid for delivery into the balloon 750.

Generally, the inflation device includes a barrel or housing 752 and apiston 754 slidably received in the barrel 752 such that a fluid-tightseal is provided between the piston 754 and barrel 752. The handle 750may include a fixed gripping surface 756 coupled to the barrel 752 and amovable gripping surface 758 coupled to the piston 754. A pressure gauge766 may be attached to the barrel 752 to provide an indicator of thepressure of fluid within the barrel 752. A filling port 768 is attachedto or extends from the barrel 752, e.g., including a valve that may beselectively opened and closed, to allow fluids (e.g., liquids or gases)to be delivered into or removed from the barrel 752. For example, whenthe balloon 750 is to be inflated, the valve may be closed to provide afixed volume of fluid for delivery into the balloon 750.

In exemplary embodiments, the valve may include a control, e.g., abutton, lever, stopcock, and the like (not shown), that may be manuallyopened and closed by the user, or the valve may be automatically openedand closed, e.g., when a luer fitting or other connector (not shown) isconnected to or disconnected from the filling port 768, e.g., aluer-activated valve. The piston 754 includes one or more helicalthreads 760 on its exterior surface that may be engaged with a split nutassembly or other actuator 764. The assembly 764 may include a button762 that, when pushed or otherwise activated, disengages the split nutthreads from the piston threads 760.

During use, the distal end 724 of the catheter 720 may introduced into abody lumen, e.g., similar to other embodiments herein. To inflate theballoon 750, the piston 754 may be advanced relative to the barrel 752.For example, the user may hold the fixed gripping surface 756 with onehand and the movable gripping surface 758 with the other. The button 762on the split nut assembly 764 may be depressed to disengage the threads760, and the piston 754 may be advanced into the barrel 752 to injectfluid through the catheter 720 into the balloon 750. The button 762 maythen be released, and the threads 760 may automatically reengage.Thereafter, if it is desired to advance or retract the piston 754, themovable gripping surface 758 may be rotated and the split nut assembly762 may slide along the threads 760, e.g., to advance the piston 754further into the barrel 752. In this manner, a higher force (andresulting pressure) may be applied to the balloon 750 than by manuallyadvancing the piston 754 with the threads 760 disengaged.

It will be appreciated that elements or components shown with anyembodiment herein are exemplary for the specific embodiment and may beused on or in combination with other embodiments disclosed herein.

While the invention is susceptible to various modifications, andalternative forms, specific examples thereof have been shown in thedrawings and are herein described in detail. It should be understood,however, that the invention is not to be limited to the particular formsor methods disclosed, but to the contrary, the invention is to cover allmodifications, equivalents and alternatives falling within the scope ofthe appended claims.

1. An apparatus for treating a body lumen, the apparatus comprising: anouter member including a proximal end, a distal end sized forintroduction into a body lumen, and a first lumen extending between theproximal end and an outlet in the distal end; an inner member slidablydisposed within the first lumen, the inner member comprising a proximalend adjacent the outer member proximal end, and a distal end extendingdistally beyond the outer member distal end; a treatment element on thedistal end; and a sealing member on the distal end proximal to thetreatment element, the distal end comprising one or more passagesextending from one or more ports in the sealing member to a distal tipof the inner member, wherein the inner member is movable between adistal position wherein the sealing member is spaced from the outletsuch that fluid introduced through the first lumen passes through theoutlet into a region around the apparatus proximal to the treatmentelement, and a proximal position wherein the sealing membersubstantially seals the outlet such that fluid introduced through thefirst lumen passes through the one or more passages and into a regionaround the apparatus distal to the treatment element.
 2. The apparatusof claim 1, wherein the treatment element comprises a balloon, the innermember comprising an inflation lumen communicating with an interior ofthe balloon.
 3. The apparatus of claim 1, further comprising a distaltip on the distal end of the inner member distally beyond the treatmentelement, the distal tip comprising a guidewire lumen communicatingbetween a distal port and a side port proximal to the distal port anddistal to the treatment element.
 4. The apparatus of claim 1, furthercomprising a distal tip on the distal end of the inner member distallybeyond the treatment element, the distal tip comprising a flexiblecurved shape, and wherein the inner member is rotatable relative to theouter member for changing an orientation of the distal tip.
 5. Theapparatus of claim 1, further comprising a distal tip on the distal endof the inner member distally beyond the treatment element, the distaltip being biased to a flexible curved shape, the inner member comprisinga guidewire lumen extending between the proximal and distal ends andthrough the distal tip, the distal tip sufficiently flexible such thatthe distal tip is at least partially straightened when a guidewire isintroduced through the guidewire lumen, the distal tip biased to thecurved shape.
 6. An apparatus for treating a body lumen, the apparatuscomprising: an outer member including a proximal end, a distal end sizedfor introduction into a body lumen, and a first lumen extending betweenthe proximal and distal ends; an expandable balloon comprising aproximal end secured to the outer member distal end, and a distal endcomprising an outlet, the balloon comprising an interior communicatingwith the first lumen and the balloon outlet; an inner member slidablydisposed within the first lumen, the inner member comprising a proximalend adjacent the outer member proximal end, and a distal end adjacentthe balloon outlet; a sealing member on the inner member distal end, theinner member being movable between a first position wherein the sealingmember is spaced from the balloon outlet such that fluid introducedthrough the first lumen passes through the balloon interior and out theballoon outlet, and a second position wherein the sealing membersubstantially seals the balloon outlet such that fluid introducedthrough the first lumen enters the balloon interior to expand theballoon; and a tensioning element between a stop in the balloon distalend and the inner member distal end for biasing the inner member towardsthe second position.
 7. The apparatus of claim 6, further comprising ahandle on the outer member proximal end, and an actuator on the handlefor directing the inner member between the first and second positions.8. The apparatus of claim 7, wherein the tensioning element is biased toautomatically direct the inner member from the first position to thesecond position when the actuator is released.
 9. The apparatus of claim7, wherein the actuator is configured to overcome the bias of thetensioning element to direct the inner member from the second positionto the first position.
 10. The apparatus of claim 6, wherein the innermember extends through the balloon outlet such that the sealing memberis disposed distal to the outlet, and wherein the inner member distalend has a cross-section smaller than the balloon outlet such that anannular lumen is defined between the inner member and the balloon outletfor delivering fluid from the balloon interior through the balloonoutlet when the inner member is in the first position.
 11. The apparatusof claim 6, wherein the sealing member is disposed within the ballooninterior in the first position, and wherein the sealing member isdisposed at least partially within the balloon distal end in the secondposition.
 12. The apparatus of claim 11, wherein the balloon distal endand the sealing member comprise stops that engage one another to limitdistal advancement of the inner member in the second position.
 13. Theapparatus of claim 11, wherein sealing member comprising a valve bodysized to be received through the balloon distal end in the secondposition, and one or more valve seals on the valve body that slidablyengage an inner surface of the balloon distal end for substantiallysealing the outlet.
 14. The apparatus of claim 6, wherein the innermember has a cross-section smaller than the first lumen such that anannular lumen is defined between the inner member and the outer memberfor delivering fluid from the outer member proximal end into the ballooninterior.
 15. An apparatus for treating a body lumen, the apparatuscomprising: an outer member including a proximal end, a distal end sizedfor introduction into a body lumen, and a first lumen extending betweenthe proximal and distal ends; an expandable balloon comprising aproximal end secured to the outer member distal end, and a distal endcomprising an outlet, the balloon comprising an interior communicatingwith the first lumen and the balloon outlet; an inner member slidablydisposed within the first lumen, the inner member comprising a proximalend adjacent the outer member proximal end, and a distal end within theballoon interior adjacent the balloon outlet; a sealing member on theinner member distal end; a handle on the outer member proximal end; andan actuator on the handle coupled to the inner member for directing theinner member between a proximal position wherein the sealing member isspaced from the outlet such that fluid introduced through the firstlumen passes through the outlet into a region around the apparatus, anda distal position wherein the sealing member is received at leastpartially within the balloon distal end to substantially seal theoutlet.
 16. The apparatus of claim 15, further comprising a tensioningelement coupled between a stop in the balloon distal end and the sealingmember for biasing the sealing member towards the proximal position. 17.The apparatus of claim 15, further comprising a tensioning elementcoupled between the proximal and distal ends of the balloon for biasingthe balloon distal end distally.